Parkinson's Disease Clinical Trial
Official title:
Effects of Cholinergic Augmentation on Measures of Balance and Gait
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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