Effects of Cholinergic Augmentation on Measures of Balance and Gait
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|ClinicalTrials.gov Identifier: NCT02206620|
Recruitment Status : Unknown
Verified July 2014 by John G. Nutt, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : August 1, 2014
Last Update Posted : August 1, 2014
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Donepezil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Cholinergic Augmentation on Measures of Balance and Gait|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Donepezil 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.
Other Name: Aricept
Placebo Comparator: 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.
Other Name: Aricept
- Examine the effects of a cholinesterase inhibitor, donepezil, on postural standing sway with and without a dual cognitive task. [ Time Frame: Up to four years ]Increased body sway while standing and enhancement of the sway by dual tasking are markers for increased risk of falling in Parkinson's disease. Sway will be measured with an inertial sensor attached to the waist.
- Variability of step length while walking and its increase with dual tasking [ Time Frame: Four years ]Variability in step length and an increase with dual tasking is another marker for increased fall risk in Parkinson' disease. This step length or duration ariability will be measured with inertial sensors attached to both feet.
- Examine the effects of a cholinesterase inhibitor, donepezil, on physiological markers of mobility associated with falls in PD (postural sway in stance and gait variability). [ Time Frame: Up to four years ]The second marker: increased gait variability and augmentation with dual-tasking.
- Short-latency afferent inhibition is a marker of cortical cholinergic activity [ Time Frame: Four years ]Short-latency afferent inhibition by a peripheral stimulation is a transcranial magnetic stimulation method to evaluate cortical cholinergic activity. Short-latency afferent Inhibition will be used to determine if our subjects with Parkinson's disease have evidence of reduced cholinergic tone which correlates with their measures of postural and gait instability. Also changes in short-latency afferent inhibition with donepezil will be a measure of pharmacological efficacy of donepezil.
- Attention Network Test [ Time Frame: Four years ]Attention Network Test (ANT) is 15 minute computerized test or reaction times with various cues and targets designed to assess alerting, orienting and executive control of attention. Deficits of attention are related to fall risk and may be affected by donepezil.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206620
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: Andrew Fraser, BS 503-418-4387 firstname.lastname@example.org|
|Principal Investigator: John Nutt, MD|
|Principal Investigator:||John Nutt, M.D.||Oregon Health and Science University|