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Research fails to justify post-COVID-19 wave of new-onset parkinsonism
, a multinational team of researchers reported at the International Congress of Parkinson’s Disease and Movement Disorders.
SARS-CoV-2 led to numerous discussions about a potential post–COVID-19 emergence of new-onset parkinsonism in susceptible individuals, often referred to in the literature as a “perfect storm” or a “wave” of parkinsonism, according to lead study author Iro Boura, MD.
Postviral precedence
“Although pathogens have been associated both with parkinsonism cases and Parkinson’s disease pathogenesis, the main concern of a potential connection between COVID-19 and new-onset parkinsonism arose from the historically documented parkinsonism cases appearing with encephalitis lethargica,” said Dr. Boura, a PhD candidate with the University of Crete in Greece and ex-fellow at King’s College London.
Encephalitis lethargica appeared between 1916 and 1930 and has been epidemiologically related to the Spanish influenza pandemic, “although this link has been strongly debated by other researchers,” she added.
Because the connection of COVID-19 and parkinsonism seemed highly speculative, Dr. Boura and movement disorder specialist Kallol Ray Chaudhuri DSc, FRCP, MD, decided to search for any data supporting this notion. “Such a possibility would have a significant impact on everyday practice, including long follow-up neurological assessments of COVID-19 patients, along with greater vigilance in recognizing potential symptoms,” said Dr. Boura.
They found no organized research exploring this link, aside from published case reports.
Scant evidence of a parkinsonism wave
The investigators conducted a review of the literature up to February 2022 to identify and analyze published cases of new-onset parkinsonism following a confirmed SARS-CoV-2 infection in otherwise healthy individuals. They ended up with 20 such cases.
Although some cases presented during or shortly after a COVID-19 infection, “the numbers are currently quite low to draw safe conclusions and generalize these findings as a risk of parkinsonism for the general population,” said Dr. Boura. Overall, parkinsonism appeared in the context of encephalopathy in 11 patients. Four patients developed postinfectious parkinsonism without encephalopathy. Another four had phenotypic similarities to idiopathic Parkinson’s disease.
Nine patients were responsive to levodopa, while four required immunomodulatory treatment.
Although cases have already been reported, current data do not yet justify the concept of a post–COVID-19 parkinsonism wave. However, long-term surveillance is crucial to ensure that reports of further cases are carefully documented and analyzed.
Dr. Chaudhuri’s research team recently wrote a book exploring the numerous aspects of COVID-19 and parkinsonism, including Parkinson’s disease, said Dr. Boura.
“Moreover, the COVID-19 Clinical Neuroscience Study (COVID-CNS), with serial follow-up visits for COVID-19 patients, including imaging, is currently running in the United Kingdom with the active participation of Prof Chaudhuri’s team, aiming at revealing any potential parkinsonism cases after a COVID-19 infection,” she said.
, a multinational team of researchers reported at the International Congress of Parkinson’s Disease and Movement Disorders.
SARS-CoV-2 led to numerous discussions about a potential post–COVID-19 emergence of new-onset parkinsonism in susceptible individuals, often referred to in the literature as a “perfect storm” or a “wave” of parkinsonism, according to lead study author Iro Boura, MD.
Postviral precedence
“Although pathogens have been associated both with parkinsonism cases and Parkinson’s disease pathogenesis, the main concern of a potential connection between COVID-19 and new-onset parkinsonism arose from the historically documented parkinsonism cases appearing with encephalitis lethargica,” said Dr. Boura, a PhD candidate with the University of Crete in Greece and ex-fellow at King’s College London.
Encephalitis lethargica appeared between 1916 and 1930 and has been epidemiologically related to the Spanish influenza pandemic, “although this link has been strongly debated by other researchers,” she added.
Because the connection of COVID-19 and parkinsonism seemed highly speculative, Dr. Boura and movement disorder specialist Kallol Ray Chaudhuri DSc, FRCP, MD, decided to search for any data supporting this notion. “Such a possibility would have a significant impact on everyday practice, including long follow-up neurological assessments of COVID-19 patients, along with greater vigilance in recognizing potential symptoms,” said Dr. Boura.
They found no organized research exploring this link, aside from published case reports.
Scant evidence of a parkinsonism wave
The investigators conducted a review of the literature up to February 2022 to identify and analyze published cases of new-onset parkinsonism following a confirmed SARS-CoV-2 infection in otherwise healthy individuals. They ended up with 20 such cases.
Although some cases presented during or shortly after a COVID-19 infection, “the numbers are currently quite low to draw safe conclusions and generalize these findings as a risk of parkinsonism for the general population,” said Dr. Boura. Overall, parkinsonism appeared in the context of encephalopathy in 11 patients. Four patients developed postinfectious parkinsonism without encephalopathy. Another four had phenotypic similarities to idiopathic Parkinson’s disease.
Nine patients were responsive to levodopa, while four required immunomodulatory treatment.
Although cases have already been reported, current data do not yet justify the concept of a post–COVID-19 parkinsonism wave. However, long-term surveillance is crucial to ensure that reports of further cases are carefully documented and analyzed.
Dr. Chaudhuri’s research team recently wrote a book exploring the numerous aspects of COVID-19 and parkinsonism, including Parkinson’s disease, said Dr. Boura.
“Moreover, the COVID-19 Clinical Neuroscience Study (COVID-CNS), with serial follow-up visits for COVID-19 patients, including imaging, is currently running in the United Kingdom with the active participation of Prof Chaudhuri’s team, aiming at revealing any potential parkinsonism cases after a COVID-19 infection,” she said.
, a multinational team of researchers reported at the International Congress of Parkinson’s Disease and Movement Disorders.
SARS-CoV-2 led to numerous discussions about a potential post–COVID-19 emergence of new-onset parkinsonism in susceptible individuals, often referred to in the literature as a “perfect storm” or a “wave” of parkinsonism, according to lead study author Iro Boura, MD.
Postviral precedence
“Although pathogens have been associated both with parkinsonism cases and Parkinson’s disease pathogenesis, the main concern of a potential connection between COVID-19 and new-onset parkinsonism arose from the historically documented parkinsonism cases appearing with encephalitis lethargica,” said Dr. Boura, a PhD candidate with the University of Crete in Greece and ex-fellow at King’s College London.
Encephalitis lethargica appeared between 1916 and 1930 and has been epidemiologically related to the Spanish influenza pandemic, “although this link has been strongly debated by other researchers,” she added.
Because the connection of COVID-19 and parkinsonism seemed highly speculative, Dr. Boura and movement disorder specialist Kallol Ray Chaudhuri DSc, FRCP, MD, decided to search for any data supporting this notion. “Such a possibility would have a significant impact on everyday practice, including long follow-up neurological assessments of COVID-19 patients, along with greater vigilance in recognizing potential symptoms,” said Dr. Boura.
They found no organized research exploring this link, aside from published case reports.
Scant evidence of a parkinsonism wave
The investigators conducted a review of the literature up to February 2022 to identify and analyze published cases of new-onset parkinsonism following a confirmed SARS-CoV-2 infection in otherwise healthy individuals. They ended up with 20 such cases.
Although some cases presented during or shortly after a COVID-19 infection, “the numbers are currently quite low to draw safe conclusions and generalize these findings as a risk of parkinsonism for the general population,” said Dr. Boura. Overall, parkinsonism appeared in the context of encephalopathy in 11 patients. Four patients developed postinfectious parkinsonism without encephalopathy. Another four had phenotypic similarities to idiopathic Parkinson’s disease.
Nine patients were responsive to levodopa, while four required immunomodulatory treatment.
Although cases have already been reported, current data do not yet justify the concept of a post–COVID-19 parkinsonism wave. However, long-term surveillance is crucial to ensure that reports of further cases are carefully documented and analyzed.
Dr. Chaudhuri’s research team recently wrote a book exploring the numerous aspects of COVID-19 and parkinsonism, including Parkinson’s disease, said Dr. Boura.
“Moreover, the COVID-19 Clinical Neuroscience Study (COVID-CNS), with serial follow-up visits for COVID-19 patients, including imaging, is currently running in the United Kingdom with the active participation of Prof Chaudhuri’s team, aiming at revealing any potential parkinsonism cases after a COVID-19 infection,” she said.
FROM MDS 2022
Resistance training tied to improvements in Parkinson’s disease symptoms
, new research suggests.
A meta-analysis, which included 18 randomized controlled trials and more than 1,000 patients with Parkinson’s disease, showed that those who underwent resistance training had significantly greater improvement in motor impairment, muscle strength, and mobility/balance than their peers who underwent passive or placebo interventions.
However, there was no significant difference between patients who participated in resistance training and those who participated in other active physical interventions, including yoga.
Overall, the results highlight the importance that these patients should participate in some type of physical exercise, said the study’s lead author, Romina Gollan, MSc, an assistant researcher in the division of medical psychology, University of Cologne, Germany. “Patients should definitely be doing exercises, including resistance training, if they want to. But the type of exercise is of secondary interest,” she said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Positive but inconsistent
Previous reviews have suggested resistance training has positive effects on motor function in Parkinson’s disease. However, results from the included studies were inconsistent; and few reviews have examined nonmotor outcomes of resistance training in this population, the investigators noted.
After carrying out a literature search of studies that examined the effects of resistance training in Parkinson’s disease, the researchers included 18 randomized controlled trials in their current review. Among the 1,134 total participants, the mean age was 66 years, the mean Hoehn & Yahr stage was 2.3 (range 0-4), and the mean duration of Parkinson’s disease was 7.5 years.
The investigation was grouped into two meta-analysis groups: one examining resistance training versus a passive or placebo intervention and the other assessing resistance training versus active physical interventions, such as yoga.
During resistance training, participants use their full strength to do a repetition, working muscles to overcome a certain threshold, said Ms. Gollan. In contrast, a placebo intervention is “very low intensity” and involves a much lower threshold, she added.
Passive interventions include such things as stretching where the stimulus “is not high enough for muscles to adapt” and build strength, Ms. Gollan noted.
A passive intervention might also include “treatment as usual” or normal daily routines.
Patient preference important
The meta-analysis comparing resistance training groups with passive control groups showed significant large effects on muscle strength (standard mean difference, –0.84; 95% confidence interval, –1.29 to –0.39; P = .0003), motor impairment (SMD, –0.81; 95% CI, –1.34 to –0.27; P = .003), and mobility and balance (SMD, –1.80; 95% CI, –3.13 to –0.49; P = .007).
The review also showed significant but small effects on quality of life.
However, the meta-analysis that assessed resistance training versus other physical interventions showed no significant between-group differences.
Ms. Gollan noted that although there were some assessments of cognition and depression, the data were too limited to determine the impact of resistance training on these outcomes.
“We need more studies, especially randomized controlled trials, to investigate the effects of resistance training on nonmotor outcomes like depression and cognition,” she said.
Co-investigator Ann-Kristin Folkerts, PhD, who heads the University of Cologne medical psychology working group, noted that although exercise in general is beneficial for patients with Parkinson’s disease, the choice of activity should take patient preferences into consideration.
It is important that patients choose an exercise they enjoy “because otherwise they probably wouldn’t adhere to the treatment,” Dr. Folkerts said. “It’s important to have fun.”
Specific goals or objectives, such as improving quality of life or balance, should also be considered, she added.
Oversimplification?
Commenting on the research, Alice Nieuwboer, PhD, professor in the department of rehabilitation sciences and head of the neurorehabilitation research group at the University of Leuven, Belgium, disagreed that exercise type is of secondary importance in Parkinson’s disease.
“In my view, it’s of primary interest, especially at the mid- to later stages,” said Dr. Nieuwboer, who was not involved with the research.
She noted it is difficult to carry out meta-analyses of resistance training versus other interventions because studies comparing different exercise types “are rather scarce.”
“Another issue is that the dose may differ, so you’re comparing apples with pears,” said Dr. Nieuwboer.
She did agree that all patients should exercise, because it is “better than no exercise,” and they should be “free to choose a mode that interests them.”
However, she stressed that exercise requires significant effort on the part of patients with Parkinson’s disease, requires “sustained motivation,” and has to become habit-forming. This makes “exercise targeting” very important, with the target changing over the disease course, Dr. Nieuwboer said.
For example, for a patient at an early stage of the disease who can still move quite well, both resistance training and endurance training can improve fitness and health; but at a mid-stage, it is perhaps better for patients to work on balance and walking quality “to preempt the risk of falls and developing freezing,” she noted.
Later on, as movement becomes very difficult, “the exercise menu is even more restricted,” said Dr. Nieuwboer.
The bottom line is that a message saying “any movement counts” is an oversimplification, she added.
The study was funded by a grant from the German Federal Ministry of Education and Research. The investigators and Dr. Nieuwboer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
A meta-analysis, which included 18 randomized controlled trials and more than 1,000 patients with Parkinson’s disease, showed that those who underwent resistance training had significantly greater improvement in motor impairment, muscle strength, and mobility/balance than their peers who underwent passive or placebo interventions.
However, there was no significant difference between patients who participated in resistance training and those who participated in other active physical interventions, including yoga.
Overall, the results highlight the importance that these patients should participate in some type of physical exercise, said the study’s lead author, Romina Gollan, MSc, an assistant researcher in the division of medical psychology, University of Cologne, Germany. “Patients should definitely be doing exercises, including resistance training, if they want to. But the type of exercise is of secondary interest,” she said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Positive but inconsistent
Previous reviews have suggested resistance training has positive effects on motor function in Parkinson’s disease. However, results from the included studies were inconsistent; and few reviews have examined nonmotor outcomes of resistance training in this population, the investigators noted.
After carrying out a literature search of studies that examined the effects of resistance training in Parkinson’s disease, the researchers included 18 randomized controlled trials in their current review. Among the 1,134 total participants, the mean age was 66 years, the mean Hoehn & Yahr stage was 2.3 (range 0-4), and the mean duration of Parkinson’s disease was 7.5 years.
The investigation was grouped into two meta-analysis groups: one examining resistance training versus a passive or placebo intervention and the other assessing resistance training versus active physical interventions, such as yoga.
During resistance training, participants use their full strength to do a repetition, working muscles to overcome a certain threshold, said Ms. Gollan. In contrast, a placebo intervention is “very low intensity” and involves a much lower threshold, she added.
Passive interventions include such things as stretching where the stimulus “is not high enough for muscles to adapt” and build strength, Ms. Gollan noted.
A passive intervention might also include “treatment as usual” or normal daily routines.
Patient preference important
The meta-analysis comparing resistance training groups with passive control groups showed significant large effects on muscle strength (standard mean difference, –0.84; 95% confidence interval, –1.29 to –0.39; P = .0003), motor impairment (SMD, –0.81; 95% CI, –1.34 to –0.27; P = .003), and mobility and balance (SMD, –1.80; 95% CI, –3.13 to –0.49; P = .007).
The review also showed significant but small effects on quality of life.
However, the meta-analysis that assessed resistance training versus other physical interventions showed no significant between-group differences.
Ms. Gollan noted that although there were some assessments of cognition and depression, the data were too limited to determine the impact of resistance training on these outcomes.
“We need more studies, especially randomized controlled trials, to investigate the effects of resistance training on nonmotor outcomes like depression and cognition,” she said.
Co-investigator Ann-Kristin Folkerts, PhD, who heads the University of Cologne medical psychology working group, noted that although exercise in general is beneficial for patients with Parkinson’s disease, the choice of activity should take patient preferences into consideration.
It is important that patients choose an exercise they enjoy “because otherwise they probably wouldn’t adhere to the treatment,” Dr. Folkerts said. “It’s important to have fun.”
Specific goals or objectives, such as improving quality of life or balance, should also be considered, she added.
Oversimplification?
Commenting on the research, Alice Nieuwboer, PhD, professor in the department of rehabilitation sciences and head of the neurorehabilitation research group at the University of Leuven, Belgium, disagreed that exercise type is of secondary importance in Parkinson’s disease.
“In my view, it’s of primary interest, especially at the mid- to later stages,” said Dr. Nieuwboer, who was not involved with the research.
She noted it is difficult to carry out meta-analyses of resistance training versus other interventions because studies comparing different exercise types “are rather scarce.”
“Another issue is that the dose may differ, so you’re comparing apples with pears,” said Dr. Nieuwboer.
She did agree that all patients should exercise, because it is “better than no exercise,” and they should be “free to choose a mode that interests them.”
However, she stressed that exercise requires significant effort on the part of patients with Parkinson’s disease, requires “sustained motivation,” and has to become habit-forming. This makes “exercise targeting” very important, with the target changing over the disease course, Dr. Nieuwboer said.
For example, for a patient at an early stage of the disease who can still move quite well, both resistance training and endurance training can improve fitness and health; but at a mid-stage, it is perhaps better for patients to work on balance and walking quality “to preempt the risk of falls and developing freezing,” she noted.
Later on, as movement becomes very difficult, “the exercise menu is even more restricted,” said Dr. Nieuwboer.
The bottom line is that a message saying “any movement counts” is an oversimplification, she added.
The study was funded by a grant from the German Federal Ministry of Education and Research. The investigators and Dr. Nieuwboer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
A meta-analysis, which included 18 randomized controlled trials and more than 1,000 patients with Parkinson’s disease, showed that those who underwent resistance training had significantly greater improvement in motor impairment, muscle strength, and mobility/balance than their peers who underwent passive or placebo interventions.
However, there was no significant difference between patients who participated in resistance training and those who participated in other active physical interventions, including yoga.
Overall, the results highlight the importance that these patients should participate in some type of physical exercise, said the study’s lead author, Romina Gollan, MSc, an assistant researcher in the division of medical psychology, University of Cologne, Germany. “Patients should definitely be doing exercises, including resistance training, if they want to. But the type of exercise is of secondary interest,” she said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Positive but inconsistent
Previous reviews have suggested resistance training has positive effects on motor function in Parkinson’s disease. However, results from the included studies were inconsistent; and few reviews have examined nonmotor outcomes of resistance training in this population, the investigators noted.
After carrying out a literature search of studies that examined the effects of resistance training in Parkinson’s disease, the researchers included 18 randomized controlled trials in their current review. Among the 1,134 total participants, the mean age was 66 years, the mean Hoehn & Yahr stage was 2.3 (range 0-4), and the mean duration of Parkinson’s disease was 7.5 years.
The investigation was grouped into two meta-analysis groups: one examining resistance training versus a passive or placebo intervention and the other assessing resistance training versus active physical interventions, such as yoga.
During resistance training, participants use their full strength to do a repetition, working muscles to overcome a certain threshold, said Ms. Gollan. In contrast, a placebo intervention is “very low intensity” and involves a much lower threshold, she added.
Passive interventions include such things as stretching where the stimulus “is not high enough for muscles to adapt” and build strength, Ms. Gollan noted.
A passive intervention might also include “treatment as usual” or normal daily routines.
Patient preference important
The meta-analysis comparing resistance training groups with passive control groups showed significant large effects on muscle strength (standard mean difference, –0.84; 95% confidence interval, –1.29 to –0.39; P = .0003), motor impairment (SMD, –0.81; 95% CI, –1.34 to –0.27; P = .003), and mobility and balance (SMD, –1.80; 95% CI, –3.13 to –0.49; P = .007).
The review also showed significant but small effects on quality of life.
However, the meta-analysis that assessed resistance training versus other physical interventions showed no significant between-group differences.
Ms. Gollan noted that although there were some assessments of cognition and depression, the data were too limited to determine the impact of resistance training on these outcomes.
“We need more studies, especially randomized controlled trials, to investigate the effects of resistance training on nonmotor outcomes like depression and cognition,” she said.
Co-investigator Ann-Kristin Folkerts, PhD, who heads the University of Cologne medical psychology working group, noted that although exercise in general is beneficial for patients with Parkinson’s disease, the choice of activity should take patient preferences into consideration.
It is important that patients choose an exercise they enjoy “because otherwise they probably wouldn’t adhere to the treatment,” Dr. Folkerts said. “It’s important to have fun.”
Specific goals or objectives, such as improving quality of life or balance, should also be considered, she added.
Oversimplification?
Commenting on the research, Alice Nieuwboer, PhD, professor in the department of rehabilitation sciences and head of the neurorehabilitation research group at the University of Leuven, Belgium, disagreed that exercise type is of secondary importance in Parkinson’s disease.
“In my view, it’s of primary interest, especially at the mid- to later stages,” said Dr. Nieuwboer, who was not involved with the research.
She noted it is difficult to carry out meta-analyses of resistance training versus other interventions because studies comparing different exercise types “are rather scarce.”
“Another issue is that the dose may differ, so you’re comparing apples with pears,” said Dr. Nieuwboer.
She did agree that all patients should exercise, because it is “better than no exercise,” and they should be “free to choose a mode that interests them.”
However, she stressed that exercise requires significant effort on the part of patients with Parkinson’s disease, requires “sustained motivation,” and has to become habit-forming. This makes “exercise targeting” very important, with the target changing over the disease course, Dr. Nieuwboer said.
For example, for a patient at an early stage of the disease who can still move quite well, both resistance training and endurance training can improve fitness and health; but at a mid-stage, it is perhaps better for patients to work on balance and walking quality “to preempt the risk of falls and developing freezing,” she noted.
Later on, as movement becomes very difficult, “the exercise menu is even more restricted,” said Dr. Nieuwboer.
The bottom line is that a message saying “any movement counts” is an oversimplification, she added.
The study was funded by a grant from the German Federal Ministry of Education and Research. The investigators and Dr. Nieuwboer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MDS 2022
Sport climbing tied to improved posture in Parkinson’s disease
In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.
The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.
“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,” said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Common feature of Parkinson’s disease
The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.
The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.
Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.
Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”
The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.
The researchers randomly assigned participants to a sport climbing course or to a control group.
The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.
The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.
Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
Whole-body workout
The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.
The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus 7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.
The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.
She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”
There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.
In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.
As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.
Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.
The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
‘Quite adventurous’
Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”
“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.
She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.
However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”
Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.
The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.
“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,” said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Common feature of Parkinson’s disease
The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.
The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.
Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.
Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”
The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.
The researchers randomly assigned participants to a sport climbing course or to a control group.
The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.
The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.
Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
Whole-body workout
The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.
The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus 7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.
The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.
She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”
There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.
In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.
As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.
Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.
The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
‘Quite adventurous’
Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”
“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.
She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.
However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”
Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized controlled study, those who participated in scaling a wall using ropes and fixed anchors were less stooped at 12 weeks than was a control group that participated in some form of unsupervised physical activity.
The results underscore that it is never too late to learn a new sport or type of movement – and that this type of intervention may have big health payoffs, said study investigator Heidemarie Zach, MD, associate professor of neurology, Medical University of Vienna, Austria.
“There’s no hurdle too high over which you can’t climb, or burden you can’t conquer,” said Dr. Zach. “As long as you can walk independently and walk up a stair, you can go climbing.”
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Common feature of Parkinson’s disease
The analysis is part of a larger project that included a 2021 study showing a reduced Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score by almost 13 points in patients who participated in sport climbing. The activity was also significantly associated with improved bradykinesia, rigidity, and tremor.
The current analysis focused on stooped posture, which in addition to motor symptoms is a common feature of Parkinson’s disease. This postural deformity can result in significant discomfort, pain, and decreased quality of life.
Pharmaceutical treatments are mostly ineffective for postural deformities, the researchers noted. Physical therapy may help improve symptoms, but only a few randomized studies have examined improved posture in patients with Parkinson’s disease using physiotherapy in general and alternative sports in particular.
Sport climbing is “really unique” in Parkinson’s disease, said Dr. Zach, who has yet to come across other research on this intervention. A climber herself, she recommended it to one of her patients: A 79-year old man with Parkinson’s disease who was a walker and hiker, and who ended up loving the sport. She called him her “pilot patient.”
The single-center study included 48 adult participants up to age 78 years (mean age, 65) with mild to moderate Parkinson’s disease. Most were at Hoehn & Yahr stage 2, with some at stage 3. All had no previous climbing experience. Exclusion criteria included having a condition other than Parkinson’s disease.
The researchers randomly assigned participants to a sport climbing course or to a control group.
The sport climbing group had a 90-minute climbing session each week for 12 weeks in an indoor gym. Under the supervision of an instructor, they were harnessed and connected to ropes with mats placed on the ground for safety.
The climbing wall was about 15 meters (50 feet) high. Participants typically started at 2 or 3 meters (6.5 to 9.5 feet) and worked their way up, Dr. Zach noted.
Those in the control group were asked to participate for 12 weeks in unsupervised physical activity, as recommended by the World Health Organization and the European Physiotherapy Guidelines for Parkinson’s Disease. This included at least 2.5 hours of moderate-intensity activity or 75 minutes of vigorous activity each week.
Whole-body workout
The primary outcome was improvement in posture, measured using a “simple” but highly reliable tool, said Dr. Zach. While the patients stood with their backs straight against a wall, researchers measured the distance in centimeters between the C7 sagittal vertical axis (C7SVA) and the wall.
The mean C7SVA at baseline did not significantly differ between the two groups, at 8.2 cm for the climbing group versus 7.7 cm for the control group. However, results showed only sport climbing was associated with significantly lessened forward flexion of the cervical spine.
The climbing group showed a decrease of the C7SVA by 1.7 cm (95% confidence interval [CI], 0.8-2.6 cm). “So climbers were more erect and less stooped after 12 weeks,” Dr. Zach said.
She noted that the mean difference in the control group was 0.5 cm (95% confidence interval [CI], –0.2 to 1.3 cm), which “is almost nothing.”
There did not seem to be any predictor, such as age, sex, or body mass index, for what patient subgroups benefit the most from the intervention, Dr. Zach noted.
In explaining why climbing helps posture, she said it is akin to “a whole-body workout.” The activity increases upper-body strength by using back and shoulder girdle muscles, as well as joint flexibility, Dr. Zach noted. Movements involved in climbing, such as repeated reaching for a distant hold, stretch the muscles of the hip flexors and hip.
As these movements reduce rigidity, the climbing action may also promote an upright posture. And as wall climbing involves planning and executing movements, it trains spatial body awareness, an important component of maintaining and correcting posture, she said.
Dr. Zach noted a motivational group dynamic likely also contributed to the success of the intervention. “They were cheering each other at the bottom” of the climbing wall, she said.
The results show that posture can be added to the improvements in Parkinson’s disease already documented from climbing, including improved motor symptoms, rigidity, and tremor, she said. The next step on the research agenda is to show whether the intervention has a positive impact on gait, Dr. Zach added.
‘Quite adventurous’
Commenting on the research, Rebecca Gilbert, MD, PhD, chief scientific officer at the American Parkinson Disease Association, said she welcomes “any new idea” to help patients with Parkinson’s disease – and that sport climbing sounds “quite adventurous.”
“The general concept that you’re asking the body to move in a novel way is a good thing for everyone and especially for people with Parkinson’s disease,” said Dr. Gilbert, who was not involved with the research.
She noted that in Parkinson’s disease, an ideal exercise intervention includes a combination of four modalities: stretching, balance, aerobics, and strengthening. Rope climbing involves many of these, in addition to a cognitive element, Dr. Gilbert said. It’s also important that patients with Parkinson’s disease participate in an activity they enjoy, she added.
However, she stressed that safety has to be “weighed,” especially for patients with stage 3 Parkinson’s disease, who often have balance problems. “It may be difficult to climb a rope if you have balance problems,” Dr. Gilbert said. “The intervention needs to be tailored to the existing disability, and perhaps this activity is more a reasonable thing for patients at milder stages.”
Dr. Zach and Dr. Gilbert have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MDS 2022
Is vitamin B12 protective against Parkinson’s disease?
A high baseline intake of vitamin B12 is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B12 may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
B vitamins and Parkinson’s disease
Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.
The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.
Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B6, and vitamin B12 over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.
During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.
The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.
Analyses of cumulative average total folate, B6, and B12 intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.
Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.
However, when examining baseline intake of vitamin B12, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.
Among individuals with higher total intake of vitamin B12, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.
Dietary sources of vitamin B12 include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
Several limitations
In an attempt to overcome risk for reverse causality, the researchers examined B12 intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.
Overall, the study results provide support for a possible protective effect of early intake of vitamin B12 on the development of Parkinson’s disease, Dr. Flores noted.
In addition to being involved in the regulation of homocysteine levels, vitamin B12 may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.
However, the study did not examine how B12 deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.
He added that although findings from a single study cannot translate into recommendations on ideal vitamin B12 intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.
Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”
As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.
Dr. Flores also stressed that the effect of B12 on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B12.”
Not ready to recommend
Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B12 may be preventive and a possible treatment in Parkinson’s disease.
“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.
However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B12 either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.
He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B6, and B12 intake” in the current study.
The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A high baseline intake of vitamin B12 is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B12 may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
B vitamins and Parkinson’s disease
Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.
The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.
Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B6, and vitamin B12 over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.
During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.
The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.
Analyses of cumulative average total folate, B6, and B12 intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.
Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.
However, when examining baseline intake of vitamin B12, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.
Among individuals with higher total intake of vitamin B12, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.
Dietary sources of vitamin B12 include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
Several limitations
In an attempt to overcome risk for reverse causality, the researchers examined B12 intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.
Overall, the study results provide support for a possible protective effect of early intake of vitamin B12 on the development of Parkinson’s disease, Dr. Flores noted.
In addition to being involved in the regulation of homocysteine levels, vitamin B12 may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.
However, the study did not examine how B12 deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.
He added that although findings from a single study cannot translate into recommendations on ideal vitamin B12 intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.
Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”
As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.
Dr. Flores also stressed that the effect of B12 on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B12.”
Not ready to recommend
Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B12 may be preventive and a possible treatment in Parkinson’s disease.
“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.
However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B12 either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.
He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B6, and B12 intake” in the current study.
The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A high baseline intake of vitamin B12 is linked to lower risk of developing Parkinson’s disease, new research suggests. “The results leave the door open for the possibility that vitamin B12 may have a beneficial effect in protecting against Parkinson’s disease,” said lead author Mario H. Flores, PhD, a research fellow at Harvard T.H. Chan School of Public Health, Boston.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
B vitamins and Parkinson’s disease
Previous preclinical studies have suggested that B vitamins protect against Parkinson’s disease by decreasing plasma homocysteine levels and through other neuroprotective effects. However, there have been only two epidemiologic studies of B vitamins in Parkinson’s disease – and their results were inconsistent, Dr. Flores noted.
The new study included 80,965 women from the Nurses’ Health Study and 48,837 men from the Health Professionals Follow-up Study. All completed a food frequency questionnaire at baseline and every 4 years.
Researchers collected information on dietary, supplemental, and total intake of folate, vitamin B6, and vitamin B12 over the course of about 30 years up to 2012. They estimated hazard ratios and 95% confidence intervals for Parkinson’s disease according to quintiles of cumulative average intake.
During follow-up, 495 women and 621 men were diagnosed with Parkinson’s disease.
The investigators adjusted for potential confounders, including age, year, smoking status, physical activity, intake of alcohol or caffeine, hormone use (in women), intake of dairy and flavonoids, and Mediterranean diet score.
Analyses of cumulative average total folate, B6, and B12 intake were not associated with Parkinson’s disease risk. “The results of the primary analysis of cumulative intake were not significant for any of the vitamins we looked at,” said Dr. Flores.
Researchers also conducted secondary analyses, including assessment of how the most recent intake of B vitamins related to Parkinson’s disease risk. This analysis also did not find a significant association.
However, when examining baseline intake of vitamin B12, “we saw some suggestion for a potential inverse association with Parkinson’s disease,” Dr. Flores said.
Among individuals with higher total intake of vitamin B12, there was a lower risk for Parkinson’s disease (pooled hazard ratio for top vs. bottom quintile, 0.74; 95% confidence interval [CI], 0.60-0.89; P for trend, .001). Intake from both diet and supplements contributed to this inverse association, the investigators noted.
Dietary sources of vitamin B12 include poultry, meat, fish, and dairy products; however, the main sources in this study were multivitamins/supplements and enriched foods such as cereals, said Dr. Flores.
Several limitations
In an attempt to overcome risk for reverse causality, the researchers examined B12 intake during four lagged exposure periods: 8-, 12-, 16- and 20-year lags. They found a significant relationship between intake for the 20-year lag time and development of Parkinson’s disease.
Overall, the study results provide support for a possible protective effect of early intake of vitamin B12 on the development of Parkinson’s disease, Dr. Flores noted.
In addition to being involved in the regulation of homocysteine levels, vitamin B12 may help regulate leucine-rich repeat kinase 2 (LRRK2), an enzyme implicated in the pathogenesis of Parkinson’s disease, he said.
However, the study did not examine how B12 deficiency might relate to risk for Parkinson’s disease, which “is something worth looking at in future studies,” said Dr. Flores.
He added that although findings from a single study cannot translate into recommendations on ideal vitamin B12 intake to prevent or delay Parkinson’s disease onset, the median intake in the highest quintile that the study linked to less Parkinson’s disease risk was 18 mcg/d at baseline. The amount in multivitamins can vary from 5 to 25 mcg.
Dr. Flores said a limitation of the study was that it included U.S. health care professionals, “most of whom arguably have very good nutritional status.”
As well, assessment of vitamin B intake was self-reported, so there might have been measurement error – and there may have been an unmeasured confounding factor that could explain the associations.
Dr. Flores also stressed that the effect of B12 on Parkinson’s disease risk “was very modest,” and the results need to be confirmed in other studies “ideally looking at circulating levels of vitamin B12.”
Not ready to recommend
Commenting on the research, Michael S. Okun, MD, medical adviser at the Parkinson’s Foundation and professor and director of the Norman Fixel Institute for Neurological Diseases at the University of Florida, Gainesville, noted that other recent studies have suggested high-dose B12 may be preventive and a possible treatment in Parkinson’s disease.
“Although only a secondary aim of the current study, there was a reported potential benefit” in this new study, too, said Dr. Okun, who was not involved with the research.
However, the evidence is still not strong enough to change prescribing habits, he noted. “We do not recommend high-dose B12 either for those at genetic risk of Parkinson’s or those already with the disease,” Dr. Okun said.
He added that because multiple recent studies have questioned the beneficial effects for multivitamin combinations used to prevent neurologic diseases, “it wasn’t surprising to see results showing a lack of protection against later-onset Parkinson’s disease with [cumulative] folate, B6, and B12 intake” in the current study.
The study was supported by the NIH. Dr. Flores and Dr. Okun have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MDS 2022
COVID vaccination does not appear to worsen symptoms of Parkinson’s disease
Nonmotor symptoms seemed to improve after SARS-CoV-2 vaccination, although the investigators could not verify a causal relationship.
Vaccination programs should continue for patients with Parkinson’s disease, they said, reporting their clinical results at the International Congress of Parkinson’s Disease and Movement Disorders.
The International Parkinson and Movement Disorder Society has recommended vaccining patients with Parkinson’s disease. “All approved mRNA-based and viral vector vaccines are not expected to interact with Parkinson’s disease, but patients [still] report concern with regard to the benefits, risks, and safeness in Parkinson’s disease,” Mayela Rodríguez-Violante, MD, MSc, and colleagues wrote in an abstract of their findings.
Social isolation may be contributing to these beliefs and concerns, though this is inconclusive.
Investigators from Mexico City conducted a retrospective study of patients with Parkinson’s disease to see how COVID-19 vaccination affected motor and nonmotor symptoms. They enlisted 60 patients (66.7% were male; aged 65.7 ± 11.35 years) who received either a vector-viral vaccine (Vaxzevria Coronavirus) or an mRNA vaccine (BNT162b2).
A Wilcoxon signed-rank test assessed scale differences before and after vaccination, measuring motor involvement (Unified Parkinson’s Disease Rating Scale), nonmotor involvement (Non-Motor Rating Scale [NMSS]), cognitive impairment (Montreal Cognitive Assessment), and quality of life (8-item Parkinson’s Disease Questionnaire index).
Investigators found no significant difference between scales, although they did notice a marked improvement in non-motor symptoms.
“The main takeaway is that vaccination against COVID-19 does not appear to worsen motor or nonmotor symptoms in persons with Parkinson’s disease. The benefits outweigh the risks,” said Dr. Rodríguez-Violante, the study’s lead author and a movement disorder specialist at the National Institute of Neurology and Neurosurgery, Mexico City.
Next steps are to increase the sample size to see if it’s possible to have a similar number in terms of type of vaccine, said Dr. Rodríguez-Violante. “Also, the data presented refers to primary series doses so booster effects will also be studied.”
Few studies have looked at vaccines and their possible effects on this patient population. However, a 2021 study of 181 patients with Parkinson’s disease reported that 2 (1.1%) had adverse effects after receiving the BNT162b2 mRNA vaccine. One of the patients, a 61-year-old woman with a decade-long history of Parkinson’s disease, developed severe, continuous, generalized dyskinesia 6 hours after a first dose of vaccine. The second patient was 79 years old and had Parkinson’s disease for 5 years. She developed fever, confusion, delusions, and continuous severe dyskinesia for 3 days following her vaccination.
“This highlights that there is a variability in the response triggered by the vaccine that might likely depend on individual immunological profiles … clinicians should be aware of this possibility and monitor their patients after they receive their vaccination,” Roberto Erro, MD, PhD and colleagues wrote in the Movement Disorders journal.
Nonmotor symptoms seemed to improve after SARS-CoV-2 vaccination, although the investigators could not verify a causal relationship.
Vaccination programs should continue for patients with Parkinson’s disease, they said, reporting their clinical results at the International Congress of Parkinson’s Disease and Movement Disorders.
The International Parkinson and Movement Disorder Society has recommended vaccining patients with Parkinson’s disease. “All approved mRNA-based and viral vector vaccines are not expected to interact with Parkinson’s disease, but patients [still] report concern with regard to the benefits, risks, and safeness in Parkinson’s disease,” Mayela Rodríguez-Violante, MD, MSc, and colleagues wrote in an abstract of their findings.
Social isolation may be contributing to these beliefs and concerns, though this is inconclusive.
Investigators from Mexico City conducted a retrospective study of patients with Parkinson’s disease to see how COVID-19 vaccination affected motor and nonmotor symptoms. They enlisted 60 patients (66.7% were male; aged 65.7 ± 11.35 years) who received either a vector-viral vaccine (Vaxzevria Coronavirus) or an mRNA vaccine (BNT162b2).
A Wilcoxon signed-rank test assessed scale differences before and after vaccination, measuring motor involvement (Unified Parkinson’s Disease Rating Scale), nonmotor involvement (Non-Motor Rating Scale [NMSS]), cognitive impairment (Montreal Cognitive Assessment), and quality of life (8-item Parkinson’s Disease Questionnaire index).
Investigators found no significant difference between scales, although they did notice a marked improvement in non-motor symptoms.
“The main takeaway is that vaccination against COVID-19 does not appear to worsen motor or nonmotor symptoms in persons with Parkinson’s disease. The benefits outweigh the risks,” said Dr. Rodríguez-Violante, the study’s lead author and a movement disorder specialist at the National Institute of Neurology and Neurosurgery, Mexico City.
Next steps are to increase the sample size to see if it’s possible to have a similar number in terms of type of vaccine, said Dr. Rodríguez-Violante. “Also, the data presented refers to primary series doses so booster effects will also be studied.”
Few studies have looked at vaccines and their possible effects on this patient population. However, a 2021 study of 181 patients with Parkinson’s disease reported that 2 (1.1%) had adverse effects after receiving the BNT162b2 mRNA vaccine. One of the patients, a 61-year-old woman with a decade-long history of Parkinson’s disease, developed severe, continuous, generalized dyskinesia 6 hours after a first dose of vaccine. The second patient was 79 years old and had Parkinson’s disease for 5 years. She developed fever, confusion, delusions, and continuous severe dyskinesia for 3 days following her vaccination.
“This highlights that there is a variability in the response triggered by the vaccine that might likely depend on individual immunological profiles … clinicians should be aware of this possibility and monitor their patients after they receive their vaccination,” Roberto Erro, MD, PhD and colleagues wrote in the Movement Disorders journal.
Nonmotor symptoms seemed to improve after SARS-CoV-2 vaccination, although the investigators could not verify a causal relationship.
Vaccination programs should continue for patients with Parkinson’s disease, they said, reporting their clinical results at the International Congress of Parkinson’s Disease and Movement Disorders.
The International Parkinson and Movement Disorder Society has recommended vaccining patients with Parkinson’s disease. “All approved mRNA-based and viral vector vaccines are not expected to interact with Parkinson’s disease, but patients [still] report concern with regard to the benefits, risks, and safeness in Parkinson’s disease,” Mayela Rodríguez-Violante, MD, MSc, and colleagues wrote in an abstract of their findings.
Social isolation may be contributing to these beliefs and concerns, though this is inconclusive.
Investigators from Mexico City conducted a retrospective study of patients with Parkinson’s disease to see how COVID-19 vaccination affected motor and nonmotor symptoms. They enlisted 60 patients (66.7% were male; aged 65.7 ± 11.35 years) who received either a vector-viral vaccine (Vaxzevria Coronavirus) or an mRNA vaccine (BNT162b2).
A Wilcoxon signed-rank test assessed scale differences before and after vaccination, measuring motor involvement (Unified Parkinson’s Disease Rating Scale), nonmotor involvement (Non-Motor Rating Scale [NMSS]), cognitive impairment (Montreal Cognitive Assessment), and quality of life (8-item Parkinson’s Disease Questionnaire index).
Investigators found no significant difference between scales, although they did notice a marked improvement in non-motor symptoms.
“The main takeaway is that vaccination against COVID-19 does not appear to worsen motor or nonmotor symptoms in persons with Parkinson’s disease. The benefits outweigh the risks,” said Dr. Rodríguez-Violante, the study’s lead author and a movement disorder specialist at the National Institute of Neurology and Neurosurgery, Mexico City.
Next steps are to increase the sample size to see if it’s possible to have a similar number in terms of type of vaccine, said Dr. Rodríguez-Violante. “Also, the data presented refers to primary series doses so booster effects will also be studied.”
Few studies have looked at vaccines and their possible effects on this patient population. However, a 2021 study of 181 patients with Parkinson’s disease reported that 2 (1.1%) had adverse effects after receiving the BNT162b2 mRNA vaccine. One of the patients, a 61-year-old woman with a decade-long history of Parkinson’s disease, developed severe, continuous, generalized dyskinesia 6 hours after a first dose of vaccine. The second patient was 79 years old and had Parkinson’s disease for 5 years. She developed fever, confusion, delusions, and continuous severe dyskinesia for 3 days following her vaccination.
“This highlights that there is a variability in the response triggered by the vaccine that might likely depend on individual immunological profiles … clinicians should be aware of this possibility and monitor their patients after they receive their vaccination,” Roberto Erro, MD, PhD and colleagues wrote in the Movement Disorders journal.
FROM MDS 2022
Telehealth effective in managing patients with movement disorders
Researchers presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Serving the underserved
One of the studies – from Kenya, Africa – documented a 2-year experience with telemedicine in a rural patient population.
Kenya suffers from a dearth of neurologists and movement disorder specialists. Most are based in the capital city of Nairobi, “leaving regions with a population of more than 30 million without access to their care,” wrote the study’s investigators. Internists with an interest in neurology usually manage the bulk of these patients.
Telemedicine has helped to bridge gaps between providers in this part of Africa.
Investigators in their study reviewed all cases of movement disorders at Meru Teaching and Referral Hospital and an affiliated clinic, Oregon Health Services, Meru, Kenya, during 2020 and 2021.
They also reviewed WhatsApp messaging, video calls via WhatsApp, patient videos, and phone calls to see how final diagnoses were arrived at using these platforms.
“For instance, a relative would send a video of a patient experiencing a tremor,” explained lead study author Bundi Karau, MD, a consultant physician. “We also shared the diagnostic challenges with experienced neurologists in Kenya and abroad by forwarding WhatsApp and recorded videos of the patients,” he added.
Telemedicine bridged the gap between rural doctors and patients in several ways. It enabled physicians to discuss cases with neurologists in and out of Kenya. “We were able to advise on medical management or further investigations in a more structured pattern and without spending months to make a diagnosis,” said Dr. Karau.
Patients no longer had to travel to Nairobi for care. “Where a direct link could be expensive or out of reach, we bridged this and consequently brought care closer to the patient,” he added.
More than 100 patients were diagnosed with a movement disorder and enrolled in care and follow-up during this 2-year time. Patients averaged about 62 years of age and more than 60% were male. Parkinson’s disease was the most common diagnosed condition (38.9%) followed by drug-induced movement disorders (30.6%), dystonia (11.1%), and functional movement disorders (11.1%).
Investigators found 3 cases of diabetic striatopathy, 8 cases of myoclonus, and 2 cases of Sydenham’s chorea.
Looking ahead, Dr. Karau and colleagues plan to do a cost benefit analysis vis-a-vis traditional physician visits and a trial model for follow-up visits for other neurological diseases.
Wearable devices and apps improve care
Moving from Africa to Greece, investigators in another study assessed the feasibility of using wearable devices to monitor symptoms in patients with Parkinson’s disease.
Such devices may enhance physical exams during virtual visits. Studies have shown that patients can commit to using such devices or mobile apps. What’s lacking is real-world data from everyday device usage, noted lead author George Rigas, PhD, and colleagues.
Fifty-two private physicians instructed a total of 133 patients to wear a device for Parkinson’s disease motor symptom telemonitoring for 1 week per month during waking hours.
Patients used a mobile app to report symptoms, medication, and nutrition adherence and to message their doctor.
The study team noticed that adherence rates stayed above 70% over a 12-month period. Medication and nutrition were among the most popular app features, an encouraging finding given that patients averaged 67 years of age.
“The high adherence percentage is significant, considering the target population and the early stage of telemedicine in Greece,” they concluded. Additional real-world data could help better inform longer-term adherence.
“These studies from all over the world demonstrate that we are only scratching the surface of the telehealth’s potential to improve care and the lives of individuals with Parkinson’s disease,” said Ray Dorsey, MD, a professor of neurology with the Center for Health + Technology at the University of Rochester (N.Y.).
Dr. Dorsey was not involved with the studies but has written and researched extensively on this topic.
Dr. Dorsey is a consultant for and has equity interests in Mediflix and Included Health, two digital health companies.
Researchers presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Serving the underserved
One of the studies – from Kenya, Africa – documented a 2-year experience with telemedicine in a rural patient population.
Kenya suffers from a dearth of neurologists and movement disorder specialists. Most are based in the capital city of Nairobi, “leaving regions with a population of more than 30 million without access to their care,” wrote the study’s investigators. Internists with an interest in neurology usually manage the bulk of these patients.
Telemedicine has helped to bridge gaps between providers in this part of Africa.
Investigators in their study reviewed all cases of movement disorders at Meru Teaching and Referral Hospital and an affiliated clinic, Oregon Health Services, Meru, Kenya, during 2020 and 2021.
They also reviewed WhatsApp messaging, video calls via WhatsApp, patient videos, and phone calls to see how final diagnoses were arrived at using these platforms.
“For instance, a relative would send a video of a patient experiencing a tremor,” explained lead study author Bundi Karau, MD, a consultant physician. “We also shared the diagnostic challenges with experienced neurologists in Kenya and abroad by forwarding WhatsApp and recorded videos of the patients,” he added.
Telemedicine bridged the gap between rural doctors and patients in several ways. It enabled physicians to discuss cases with neurologists in and out of Kenya. “We were able to advise on medical management or further investigations in a more structured pattern and without spending months to make a diagnosis,” said Dr. Karau.
Patients no longer had to travel to Nairobi for care. “Where a direct link could be expensive or out of reach, we bridged this and consequently brought care closer to the patient,” he added.
More than 100 patients were diagnosed with a movement disorder and enrolled in care and follow-up during this 2-year time. Patients averaged about 62 years of age and more than 60% were male. Parkinson’s disease was the most common diagnosed condition (38.9%) followed by drug-induced movement disorders (30.6%), dystonia (11.1%), and functional movement disorders (11.1%).
Investigators found 3 cases of diabetic striatopathy, 8 cases of myoclonus, and 2 cases of Sydenham’s chorea.
Looking ahead, Dr. Karau and colleagues plan to do a cost benefit analysis vis-a-vis traditional physician visits and a trial model for follow-up visits for other neurological diseases.
Wearable devices and apps improve care
Moving from Africa to Greece, investigators in another study assessed the feasibility of using wearable devices to monitor symptoms in patients with Parkinson’s disease.
Such devices may enhance physical exams during virtual visits. Studies have shown that patients can commit to using such devices or mobile apps. What’s lacking is real-world data from everyday device usage, noted lead author George Rigas, PhD, and colleagues.
Fifty-two private physicians instructed a total of 133 patients to wear a device for Parkinson’s disease motor symptom telemonitoring for 1 week per month during waking hours.
Patients used a mobile app to report symptoms, medication, and nutrition adherence and to message their doctor.
The study team noticed that adherence rates stayed above 70% over a 12-month period. Medication and nutrition were among the most popular app features, an encouraging finding given that patients averaged 67 years of age.
“The high adherence percentage is significant, considering the target population and the early stage of telemedicine in Greece,” they concluded. Additional real-world data could help better inform longer-term adherence.
“These studies from all over the world demonstrate that we are only scratching the surface of the telehealth’s potential to improve care and the lives of individuals with Parkinson’s disease,” said Ray Dorsey, MD, a professor of neurology with the Center for Health + Technology at the University of Rochester (N.Y.).
Dr. Dorsey was not involved with the studies but has written and researched extensively on this topic.
Dr. Dorsey is a consultant for and has equity interests in Mediflix and Included Health, two digital health companies.
Researchers presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Serving the underserved
One of the studies – from Kenya, Africa – documented a 2-year experience with telemedicine in a rural patient population.
Kenya suffers from a dearth of neurologists and movement disorder specialists. Most are based in the capital city of Nairobi, “leaving regions with a population of more than 30 million without access to their care,” wrote the study’s investigators. Internists with an interest in neurology usually manage the bulk of these patients.
Telemedicine has helped to bridge gaps between providers in this part of Africa.
Investigators in their study reviewed all cases of movement disorders at Meru Teaching and Referral Hospital and an affiliated clinic, Oregon Health Services, Meru, Kenya, during 2020 and 2021.
They also reviewed WhatsApp messaging, video calls via WhatsApp, patient videos, and phone calls to see how final diagnoses were arrived at using these platforms.
“For instance, a relative would send a video of a patient experiencing a tremor,” explained lead study author Bundi Karau, MD, a consultant physician. “We also shared the diagnostic challenges with experienced neurologists in Kenya and abroad by forwarding WhatsApp and recorded videos of the patients,” he added.
Telemedicine bridged the gap between rural doctors and patients in several ways. It enabled physicians to discuss cases with neurologists in and out of Kenya. “We were able to advise on medical management or further investigations in a more structured pattern and without spending months to make a diagnosis,” said Dr. Karau.
Patients no longer had to travel to Nairobi for care. “Where a direct link could be expensive or out of reach, we bridged this and consequently brought care closer to the patient,” he added.
More than 100 patients were diagnosed with a movement disorder and enrolled in care and follow-up during this 2-year time. Patients averaged about 62 years of age and more than 60% were male. Parkinson’s disease was the most common diagnosed condition (38.9%) followed by drug-induced movement disorders (30.6%), dystonia (11.1%), and functional movement disorders (11.1%).
Investigators found 3 cases of diabetic striatopathy, 8 cases of myoclonus, and 2 cases of Sydenham’s chorea.
Looking ahead, Dr. Karau and colleagues plan to do a cost benefit analysis vis-a-vis traditional physician visits and a trial model for follow-up visits for other neurological diseases.
Wearable devices and apps improve care
Moving from Africa to Greece, investigators in another study assessed the feasibility of using wearable devices to monitor symptoms in patients with Parkinson’s disease.
Such devices may enhance physical exams during virtual visits. Studies have shown that patients can commit to using such devices or mobile apps. What’s lacking is real-world data from everyday device usage, noted lead author George Rigas, PhD, and colleagues.
Fifty-two private physicians instructed a total of 133 patients to wear a device for Parkinson’s disease motor symptom telemonitoring for 1 week per month during waking hours.
Patients used a mobile app to report symptoms, medication, and nutrition adherence and to message their doctor.
The study team noticed that adherence rates stayed above 70% over a 12-month period. Medication and nutrition were among the most popular app features, an encouraging finding given that patients averaged 67 years of age.
“The high adherence percentage is significant, considering the target population and the early stage of telemedicine in Greece,” they concluded. Additional real-world data could help better inform longer-term adherence.
“These studies from all over the world demonstrate that we are only scratching the surface of the telehealth’s potential to improve care and the lives of individuals with Parkinson’s disease,” said Ray Dorsey, MD, a professor of neurology with the Center for Health + Technology at the University of Rochester (N.Y.).
Dr. Dorsey was not involved with the studies but has written and researched extensively on this topic.
Dr. Dorsey is a consultant for and has equity interests in Mediflix and Included Health, two digital health companies.
From MDS 2022
Medical cannabis appears safe for patients with movement disorders
, two Israeli research teams reported.
The practice calls for careful monitoring of patients and additional study, said the researchers, who presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Cannabis for Parkinson’s disease
One retrospective study focused on Parkinson’s disease, evaluating the safety and effects of long-term treatment with medical cannabis, which has become a widely available treatment for controlling symptoms in Parkinson’s disease and other pain disorders. Studies have demonstrated its efficacy in patients with Parkinson’s disease, but long-term safety has never been examined in Parkinson’s disease compared with untreated patients.
Their study included 152 patients with idiopathic Parkinson’s disease (mean age at diagnosis: 55.6 plus or minus 9.5 years) from the Sheba Medical Center Movement Disorders Institute who had been issued a license for medical cannabis. Seventy-six patients treated with cannabis were compared with 76 patients with similar characteristics who were not treated with cannabis.
Investigators collected data on patients who were followed at the institute between 2008 and 2022. Average follow-up period was 3.6 years.
Specifically, they collected data on levodopa equivalent daily dose (LEDD), Hoehn and Yahr scale progression, and patient-reported outcome measures on cognitive impairment, depressive, and psychotic symptoms, at baseline and at follow-up.
The Hoehn and Yahr scale allows for the quantification of different disease stages and LEDD provides a summary of the total daily medication a patient is receiving, explained Tomer Goldberg, BSc, the study’s lead author. Both are widely accepted motor severity and progression measures for Parkinson’s disease. “We wanted to check whether cannabis treatment influences these two motor parameters,” said Mr. Goldberg, who is affiliated with Tel Aviv University and the Movement Disorders Institute at Sheba Medical Center.
The medical cannabis–treated group and the untreated group had no significant differences in the mean annual change in LEDD or Hoehn and Yahr score. At 1, 2, and 3 years of follow-up, the treated group showed no signs of psychotic, depressive, or cognitive deterioration (P = .10-.68). The groups in Kaplan-Meier analyses also exhibited no differences in these nonmotor symptoms over time (P = .27-.93).
The findings suggest that cannabis treatment appears to be safe and has no negative effect on disease progression, said Mr. Goldberg. “It is important to note that we did not investigate all of the potential side effects of this treatment, and that prescribing medical cannabis for patients with Parkinson’s disease should be done with careful monitoring of each patient’s individual response to the treatment,” he added.
Cannabis for Huntington’s disease
Another study, targeting Huntington’s disease, drew similar conclusions. Psychiatric symptoms and cognitive decline are often present in Huntington’s disease patients, who have few treatment options. “An overall improvement in chorea and in neuropsychiatric symptoms was reported following cannabis treatment in several studies both in humans and in murine models,” wrote the study authors.
In this study, a certified Huntington’s disease specialist reviewed the medical records of 150 patients who were being followed in an Huntington’s disease clinic. Study metrics included the Unified Huntington’s Disease Rating Scale and Montreal Cognitive Assessment scores, indications for treatment, and adverse events related to treatment. Among the 150 patients, 19 had received cannabis treatment for indications such as sleep disorders, behavioral anomalies, and chorea. All but one patient reported an improvement in symptoms (94%). No adverse events were recorded, although one patient died from a COVID-19 infection.
Overall, medical cannabis appeared to safely relieve symptoms in patients with Huntington’s disease. A double-blind randomized controlled trial should further examine efficacy of these findings, the study authors recommended.
Mr. Goldberg had no disclosures or conflicts of interest in reporting his research.
, two Israeli research teams reported.
The practice calls for careful monitoring of patients and additional study, said the researchers, who presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Cannabis for Parkinson’s disease
One retrospective study focused on Parkinson’s disease, evaluating the safety and effects of long-term treatment with medical cannabis, which has become a widely available treatment for controlling symptoms in Parkinson’s disease and other pain disorders. Studies have demonstrated its efficacy in patients with Parkinson’s disease, but long-term safety has never been examined in Parkinson’s disease compared with untreated patients.
Their study included 152 patients with idiopathic Parkinson’s disease (mean age at diagnosis: 55.6 plus or minus 9.5 years) from the Sheba Medical Center Movement Disorders Institute who had been issued a license for medical cannabis. Seventy-six patients treated with cannabis were compared with 76 patients with similar characteristics who were not treated with cannabis.
Investigators collected data on patients who were followed at the institute between 2008 and 2022. Average follow-up period was 3.6 years.
Specifically, they collected data on levodopa equivalent daily dose (LEDD), Hoehn and Yahr scale progression, and patient-reported outcome measures on cognitive impairment, depressive, and psychotic symptoms, at baseline and at follow-up.
The Hoehn and Yahr scale allows for the quantification of different disease stages and LEDD provides a summary of the total daily medication a patient is receiving, explained Tomer Goldberg, BSc, the study’s lead author. Both are widely accepted motor severity and progression measures for Parkinson’s disease. “We wanted to check whether cannabis treatment influences these two motor parameters,” said Mr. Goldberg, who is affiliated with Tel Aviv University and the Movement Disorders Institute at Sheba Medical Center.
The medical cannabis–treated group and the untreated group had no significant differences in the mean annual change in LEDD or Hoehn and Yahr score. At 1, 2, and 3 years of follow-up, the treated group showed no signs of psychotic, depressive, or cognitive deterioration (P = .10-.68). The groups in Kaplan-Meier analyses also exhibited no differences in these nonmotor symptoms over time (P = .27-.93).
The findings suggest that cannabis treatment appears to be safe and has no negative effect on disease progression, said Mr. Goldberg. “It is important to note that we did not investigate all of the potential side effects of this treatment, and that prescribing medical cannabis for patients with Parkinson’s disease should be done with careful monitoring of each patient’s individual response to the treatment,” he added.
Cannabis for Huntington’s disease
Another study, targeting Huntington’s disease, drew similar conclusions. Psychiatric symptoms and cognitive decline are often present in Huntington’s disease patients, who have few treatment options. “An overall improvement in chorea and in neuropsychiatric symptoms was reported following cannabis treatment in several studies both in humans and in murine models,” wrote the study authors.
In this study, a certified Huntington’s disease specialist reviewed the medical records of 150 patients who were being followed in an Huntington’s disease clinic. Study metrics included the Unified Huntington’s Disease Rating Scale and Montreal Cognitive Assessment scores, indications for treatment, and adverse events related to treatment. Among the 150 patients, 19 had received cannabis treatment for indications such as sleep disorders, behavioral anomalies, and chorea. All but one patient reported an improvement in symptoms (94%). No adverse events were recorded, although one patient died from a COVID-19 infection.
Overall, medical cannabis appeared to safely relieve symptoms in patients with Huntington’s disease. A double-blind randomized controlled trial should further examine efficacy of these findings, the study authors recommended.
Mr. Goldberg had no disclosures or conflicts of interest in reporting his research.
, two Israeli research teams reported.
The practice calls for careful monitoring of patients and additional study, said the researchers, who presented their findings at the International Congress of Parkinson’s Disease and Movement Disorders.
Cannabis for Parkinson’s disease
One retrospective study focused on Parkinson’s disease, evaluating the safety and effects of long-term treatment with medical cannabis, which has become a widely available treatment for controlling symptoms in Parkinson’s disease and other pain disorders. Studies have demonstrated its efficacy in patients with Parkinson’s disease, but long-term safety has never been examined in Parkinson’s disease compared with untreated patients.
Their study included 152 patients with idiopathic Parkinson’s disease (mean age at diagnosis: 55.6 plus or minus 9.5 years) from the Sheba Medical Center Movement Disorders Institute who had been issued a license for medical cannabis. Seventy-six patients treated with cannabis were compared with 76 patients with similar characteristics who were not treated with cannabis.
Investigators collected data on patients who were followed at the institute between 2008 and 2022. Average follow-up period was 3.6 years.
Specifically, they collected data on levodopa equivalent daily dose (LEDD), Hoehn and Yahr scale progression, and patient-reported outcome measures on cognitive impairment, depressive, and psychotic symptoms, at baseline and at follow-up.
The Hoehn and Yahr scale allows for the quantification of different disease stages and LEDD provides a summary of the total daily medication a patient is receiving, explained Tomer Goldberg, BSc, the study’s lead author. Both are widely accepted motor severity and progression measures for Parkinson’s disease. “We wanted to check whether cannabis treatment influences these two motor parameters,” said Mr. Goldberg, who is affiliated with Tel Aviv University and the Movement Disorders Institute at Sheba Medical Center.
The medical cannabis–treated group and the untreated group had no significant differences in the mean annual change in LEDD or Hoehn and Yahr score. At 1, 2, and 3 years of follow-up, the treated group showed no signs of psychotic, depressive, or cognitive deterioration (P = .10-.68). The groups in Kaplan-Meier analyses also exhibited no differences in these nonmotor symptoms over time (P = .27-.93).
The findings suggest that cannabis treatment appears to be safe and has no negative effect on disease progression, said Mr. Goldberg. “It is important to note that we did not investigate all of the potential side effects of this treatment, and that prescribing medical cannabis for patients with Parkinson’s disease should be done with careful monitoring of each patient’s individual response to the treatment,” he added.
Cannabis for Huntington’s disease
Another study, targeting Huntington’s disease, drew similar conclusions. Psychiatric symptoms and cognitive decline are often present in Huntington’s disease patients, who have few treatment options. “An overall improvement in chorea and in neuropsychiatric symptoms was reported following cannabis treatment in several studies both in humans and in murine models,” wrote the study authors.
In this study, a certified Huntington’s disease specialist reviewed the medical records of 150 patients who were being followed in an Huntington’s disease clinic. Study metrics included the Unified Huntington’s Disease Rating Scale and Montreal Cognitive Assessment scores, indications for treatment, and adverse events related to treatment. Among the 150 patients, 19 had received cannabis treatment for indications such as sleep disorders, behavioral anomalies, and chorea. All but one patient reported an improvement in symptoms (94%). No adverse events were recorded, although one patient died from a COVID-19 infection.
Overall, medical cannabis appeared to safely relieve symptoms in patients with Huntington’s disease. A double-blind randomized controlled trial should further examine efficacy of these findings, the study authors recommended.
Mr. Goldberg had no disclosures or conflicts of interest in reporting his research.
FROM MDS 2022
A history of head trauma may predict Parkinson’s disease progression
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From MDS 2022
Novel combination treatment improves function in early Parkinson’s disease
Results from a phase 3 trial found that P2B001 was superior to its components in improving motor symptoms and daily function and was comparable with marketed doses of pramipexole.
P2B001 also produced less daytime sleepiness and fewer dopaminergic effects, said the investigators, who presented findings at the International Congress of Parkinson’s Disease and Movement Disorders.
The treatment studied, P2B001, is a proprietary, fixed-dose combination of extended-release (ER) formulations of pramipexole and rasagiline. Neither dose is currently available on the market.
Investigators wanted to test the hypothesis that two anti-Parkinsonian drugs that act through different mechanisms could work synergistically, providing benefits comparable with pramipexole but with fewer side effects, said lead study author Warren Olanow, MD, professor emeritus in the neurology and neuroscience departments at the Icahn School of Medicine at Mount Sinai, New York.
Pramipexole is problematic in that it causes dopaminergic and sleep-related side effects.
Laboratory studies have shown that low doses of pramipexole and rasagiline act synergistically, said Dr. Olanow. “A previous double-blind controlled study demonstrated that P2B001 was significantly superior to placebo with respect to efficacy (P < .001) and had a good safety and tolerability profile.”
P2B001 outperforms other formulations
The multicenter phase 3 study (NCT03329508) enrolled 544 patients aged 35-80 with early Parkinson’s disease to assess efficacy and safety of a daily dose of P2B001, compared with its components. Patients were randomized 2:2:2:1 to 12 weeks of treatment with P2B001; pramipexole ER 0.6 mg; rasagiline ER 0.75 mg, or to a calibration arm of marketed pramipexole-ER titrated to optimal dose (mean dose, 3.2 mg).
The primary endpoint compared baseline with week 12 changes in Unified Parkinson’s Disease Rating Scale total scores for P2B001 versus its individual components. The secondary endpoint compared baseline changes in Epworth Sleepiness Scale (ESS) for P2B001 versus pramipexole-ER.
P2B001 showed superior efficacy to each of its individual components and comparable efficacy with marketed doses of pramipexole-ER. It also yielded fewer adverse events related to dopaminergic side effects and less daytime sleepiness as measured by ESS. “Further, the drug is administered once a day and does not require titration,” said Dr. Olanow.
Levodopa-related benefits
Another advantage of starting early-stage patients on P2B001 is that it would give patients more time to be on an effective therapy with fewer side effects before going on levodopa, the current gold standard for Parkinson’s disease treatment.
Although the American Academy of Neurology recommends levodopa as initial therapy for Parkinson’s disease, the drug has been associated with a risk of developing motor complications.
“This opinion, however, was formulated prior to the availability of the results of the P2B001 study and should be reassessed in the light of the present study,” said Dr. Olanow. Longer-term studies should assess when and if patients will require levodopa therapy, as well as the long-term effects of P2B001 on the development of motor complications in patients with early Parkinson’s disease patients.
Investigators are preparing a regulatory market approval filing for P2B001 with the Food and Drug Administration.
Dr. Olanow is CEO of Clintrex Research Corporation, which has provided services to Pharma2B, sponsor of the phase 3 study. Pharma Two B is a private, late clinical-stage pharmaceutical company in Rehovot, Israel, that owns worldwide granted patents for P2B001 pharmaceutical composition and method of treatment.
Results from a phase 3 trial found that P2B001 was superior to its components in improving motor symptoms and daily function and was comparable with marketed doses of pramipexole.
P2B001 also produced less daytime sleepiness and fewer dopaminergic effects, said the investigators, who presented findings at the International Congress of Parkinson’s Disease and Movement Disorders.
The treatment studied, P2B001, is a proprietary, fixed-dose combination of extended-release (ER) formulations of pramipexole and rasagiline. Neither dose is currently available on the market.
Investigators wanted to test the hypothesis that two anti-Parkinsonian drugs that act through different mechanisms could work synergistically, providing benefits comparable with pramipexole but with fewer side effects, said lead study author Warren Olanow, MD, professor emeritus in the neurology and neuroscience departments at the Icahn School of Medicine at Mount Sinai, New York.
Pramipexole is problematic in that it causes dopaminergic and sleep-related side effects.
Laboratory studies have shown that low doses of pramipexole and rasagiline act synergistically, said Dr. Olanow. “A previous double-blind controlled study demonstrated that P2B001 was significantly superior to placebo with respect to efficacy (P < .001) and had a good safety and tolerability profile.”
P2B001 outperforms other formulations
The multicenter phase 3 study (NCT03329508) enrolled 544 patients aged 35-80 with early Parkinson’s disease to assess efficacy and safety of a daily dose of P2B001, compared with its components. Patients were randomized 2:2:2:1 to 12 weeks of treatment with P2B001; pramipexole ER 0.6 mg; rasagiline ER 0.75 mg, or to a calibration arm of marketed pramipexole-ER titrated to optimal dose (mean dose, 3.2 mg).
The primary endpoint compared baseline with week 12 changes in Unified Parkinson’s Disease Rating Scale total scores for P2B001 versus its individual components. The secondary endpoint compared baseline changes in Epworth Sleepiness Scale (ESS) for P2B001 versus pramipexole-ER.
P2B001 showed superior efficacy to each of its individual components and comparable efficacy with marketed doses of pramipexole-ER. It also yielded fewer adverse events related to dopaminergic side effects and less daytime sleepiness as measured by ESS. “Further, the drug is administered once a day and does not require titration,” said Dr. Olanow.
Levodopa-related benefits
Another advantage of starting early-stage patients on P2B001 is that it would give patients more time to be on an effective therapy with fewer side effects before going on levodopa, the current gold standard for Parkinson’s disease treatment.
Although the American Academy of Neurology recommends levodopa as initial therapy for Parkinson’s disease, the drug has been associated with a risk of developing motor complications.
“This opinion, however, was formulated prior to the availability of the results of the P2B001 study and should be reassessed in the light of the present study,” said Dr. Olanow. Longer-term studies should assess when and if patients will require levodopa therapy, as well as the long-term effects of P2B001 on the development of motor complications in patients with early Parkinson’s disease patients.
Investigators are preparing a regulatory market approval filing for P2B001 with the Food and Drug Administration.
Dr. Olanow is CEO of Clintrex Research Corporation, which has provided services to Pharma2B, sponsor of the phase 3 study. Pharma Two B is a private, late clinical-stage pharmaceutical company in Rehovot, Israel, that owns worldwide granted patents for P2B001 pharmaceutical composition and method of treatment.
Results from a phase 3 trial found that P2B001 was superior to its components in improving motor symptoms and daily function and was comparable with marketed doses of pramipexole.
P2B001 also produced less daytime sleepiness and fewer dopaminergic effects, said the investigators, who presented findings at the International Congress of Parkinson’s Disease and Movement Disorders.
The treatment studied, P2B001, is a proprietary, fixed-dose combination of extended-release (ER) formulations of pramipexole and rasagiline. Neither dose is currently available on the market.
Investigators wanted to test the hypothesis that two anti-Parkinsonian drugs that act through different mechanisms could work synergistically, providing benefits comparable with pramipexole but with fewer side effects, said lead study author Warren Olanow, MD, professor emeritus in the neurology and neuroscience departments at the Icahn School of Medicine at Mount Sinai, New York.
Pramipexole is problematic in that it causes dopaminergic and sleep-related side effects.
Laboratory studies have shown that low doses of pramipexole and rasagiline act synergistically, said Dr. Olanow. “A previous double-blind controlled study demonstrated that P2B001 was significantly superior to placebo with respect to efficacy (P < .001) and had a good safety and tolerability profile.”
P2B001 outperforms other formulations
The multicenter phase 3 study (NCT03329508) enrolled 544 patients aged 35-80 with early Parkinson’s disease to assess efficacy and safety of a daily dose of P2B001, compared with its components. Patients were randomized 2:2:2:1 to 12 weeks of treatment with P2B001; pramipexole ER 0.6 mg; rasagiline ER 0.75 mg, or to a calibration arm of marketed pramipexole-ER titrated to optimal dose (mean dose, 3.2 mg).
The primary endpoint compared baseline with week 12 changes in Unified Parkinson’s Disease Rating Scale total scores for P2B001 versus its individual components. The secondary endpoint compared baseline changes in Epworth Sleepiness Scale (ESS) for P2B001 versus pramipexole-ER.
P2B001 showed superior efficacy to each of its individual components and comparable efficacy with marketed doses of pramipexole-ER. It also yielded fewer adverse events related to dopaminergic side effects and less daytime sleepiness as measured by ESS. “Further, the drug is administered once a day and does not require titration,” said Dr. Olanow.
Levodopa-related benefits
Another advantage of starting early-stage patients on P2B001 is that it would give patients more time to be on an effective therapy with fewer side effects before going on levodopa, the current gold standard for Parkinson’s disease treatment.
Although the American Academy of Neurology recommends levodopa as initial therapy for Parkinson’s disease, the drug has been associated with a risk of developing motor complications.
“This opinion, however, was formulated prior to the availability of the results of the P2B001 study and should be reassessed in the light of the present study,” said Dr. Olanow. Longer-term studies should assess when and if patients will require levodopa therapy, as well as the long-term effects of P2B001 on the development of motor complications in patients with early Parkinson’s disease patients.
Investigators are preparing a regulatory market approval filing for P2B001 with the Food and Drug Administration.
Dr. Olanow is CEO of Clintrex Research Corporation, which has provided services to Pharma2B, sponsor of the phase 3 study. Pharma Two B is a private, late clinical-stage pharmaceutical company in Rehovot, Israel, that owns worldwide granted patents for P2B001 pharmaceutical composition and method of treatment.
From MDS 2022