Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-02-28

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.

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Donepezil

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

donepezil, 5 mg, capsule, once a day, 3 weeks

Sugar Pill

Group Type PLACEBO_COMPARATOR

Sugar Pill (placebo)

Intervention Type DRUG

sugar pill, one capsule, once a day, 3 weeks

Interventions

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Donepezil

donepezil, 5 mg, capsule, once a day, 3 weeks

Intervention Type DRUG

Sugar Pill (placebo)

sugar pill, one capsule, once a day, 3 weeks

Intervention Type DRUG

Other Intervention Names

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aricept

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No