Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Donepezil
* Drug: Sugar Pill (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil<br> | Drug: Donepezil<br>* donepezil, 5 mg, capsule, once a day, 3 weeks<br>* Other names: aricept;|
| Placebo Comparator: Sugar Pill<br> | Drug: Sugar Pill (placebo)<br>* sugar pill, one capsule, once a day, 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall Frequency Per Day | The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Near Falls Per Day | The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinsons disease, falling