Effects of Cholinergic Augmentation on Measures of Balance and Gait

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-07-31

Brief Summary

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This study will compare the effects of placebo and donepezil, a drug that helps conserve concentrations of the neurotransmitter, acetylcholine, on measures of balance and gait in subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled, cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a physiological index of cholinergic function will be measured to determine if the deficits in balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil as a measure of drug efficacy. Cognitive tests like the Attention Network Test (ANT) will be administered to determine if changes in gait and balance are mediated by changes in attention.

The results of this study will be the most direct test of the hypothesized role of cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The study is exploratory because it is not known whether donepezil will affect gait, balance or attention, nor which measures of gait, balance or attention will be sensitive to drug manipulation. The study's immediate goal is to determine the potential utility of cholinergic manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The findings of this trial are intended to lead to more sharply focused questions about the role of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine clinical utility of cholinergic manipulation to prevent falls and improve mobility.

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Detailed Description

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Donepezil

Donepezil 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

Placebo

Placebo 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.

Group Type PLACEBO_COMPARATOR

Donepezil

Intervention Type DRUG

Interventions

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Donepezil

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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Inclusion Criteria

* 30 years old or older
* Diagnosis of idiopathic Parkinson's disease
* Stand unassisted (without use of an assistance device) and walk continuously for at least 2 minutes.

Exclusion Criteria

* musculoskeletal disorders that affect standing and walking
* Uncorrected vision disturbance
* Vestibular problems
* Major depression
* Hallucinations or other psychiatric disturbances
* Tachycardia
* Bradycardia
* Arrhythmias
* Peptic ulcer disease
* Use of anticholinergics
* Use of cholinesterase inhibitors
* Use of bladder antispasmodics
* Use of tricyclic antidepressants

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No