The Effect of Donepezil on Gait and Balance in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2011 |
| End Date: | July 2012 |
| Contact: | Elizabeth Murdock, MS |
| Email: | murdocke@ohsu.edu |
| Phone: | 971-400-7504 |
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease
This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and
muscle rigidity. Current medications for the treatment of PD do not improve gait and balance
difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls
in individuals with PD. The mechanism in which this reduction of falls occurs is unclear.
The investigators study will look at what aspects of gait and balance are improved by the
study drug. The study drug is not approved to treat PD in the United States or other
countries because we do not know enough about it.
muscle rigidity. Current medications for the treatment of PD do not improve gait and balance
difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls
in individuals with PD. The mechanism in which this reduction of falls occurs is unclear.
The investigators study will look at what aspects of gait and balance are improved by the
study drug. The study drug is not approved to treat PD in the United States or other
countries because we do not know enough about it.
Parkinson's disease (PD) is a common neuro-degenerative disease affecting about 2% of the
adult population in the United States over the age of 65. Some of the most disabling
symptoms of Parkinson's disease are balance and gait dysfunction, leading to falls. These
symptoms do not respond to current dopamine directed therapies. Evidence from both
pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in
the thalamus and basal ganglia is found in individuals with PD who fall compared to
non-fallers. The central acting acetylcholine esterase inhibitor, donepezil, has been
demonstrated to decrease falls in individuals with PD. The mechanism by which falls
decreased is unknown. Our open label pilot data indicates that donepezil can improve
quantitative measures of balance in individuals with PD. Suggesting that improvements in
balance in the mechanism by which donepezil reduces falls. Our goal is to determine whether
donepezil will:
- Improve quantitative measures of balance in subjects with Parkinson's disease compared
to placebo.
- Improve quantitative measures of gait in subjects with Parkinson's disease compared to
placebo.
- Improve cognitive measures in non-demented subjects with Parkinson's disease.
adult population in the United States over the age of 65. Some of the most disabling
symptoms of Parkinson's disease are balance and gait dysfunction, leading to falls. These
symptoms do not respond to current dopamine directed therapies. Evidence from both
pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in
the thalamus and basal ganglia is found in individuals with PD who fall compared to
non-fallers. The central acting acetylcholine esterase inhibitor, donepezil, has been
demonstrated to decrease falls in individuals with PD. The mechanism by which falls
decreased is unknown. Our open label pilot data indicates that donepezil can improve
quantitative measures of balance in individuals with PD. Suggesting that improvements in
balance in the mechanism by which donepezil reduces falls. Our goal is to determine whether
donepezil will:
- Improve quantitative measures of balance in subjects with Parkinson's disease compared
to placebo.
- Improve quantitative measures of gait in subjects with Parkinson's disease compared to
placebo.
- Improve cognitive measures in non-demented subjects with Parkinson's disease.
Inclusion Criteria:
- Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn
and Yahr score of 2 to 4
- Treated with levodopa for at least a year and on a stable antiparkinsonian regimen
for at least one month
- Abnormal computerized dynamic posturography (CDP) on screening defined as a composite
score below 65 (range 1-100)
Exclusion Criteria:
- Dementia defined by MMSE less than 27
- Other medical conditions other than PD affecting balance or gait as determined by the
investigators
- Unable to stand unassisted for 30 minutes
- Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic
properties
- Medical or psychiatric co-morbidities that may interfere with compliance or might
place subject in danger as determined by the investigators
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