Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
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Details and patient eligibility
About
The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.
Full description
This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age over 21
- Diagnosis of Parkinson's disease
- Treated with dopaminergic medication for at least 1 year
Exclusion criteria
- Must be ambulatory (can use walker or cane)
- No obvious remediable cause of falls
- Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)
- Dementia present (MMSE < 25)
- Not taking cholinergic or anticholinergic medications 10 days prior to screening visit
- No Warfarin use
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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