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NCT02206620 · ClinicalTrials.gov registry record · Phase 2
Effects of Cholinergic Augmentation on Measures of Balance and Gait
A Phase 2 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT02206620: Completed Phase 2 study, sponsored by Oregon Health and Science University.
NCT02206620 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206620, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Increased body sway while standing may be markers for increased risk of falling in Parkinson's disease. Sway was measured with an inertial sensor attached to the waist. Participants did this task on a foam pad. We reported the delta in the donepezil and placebo phases \[post-donepezil - pre-donepezil for the donepezil phase, and post-placebo - pre-placebo for the placebo phase\].
Interventions
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
What the finished NCT02206620 record still lists
NCT02206620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Donepezil is the first listed.
NCT02206620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02206620 about?
NCT02206620 is a clinical study titled "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 ...
What is the current status of trial NCT02206620?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2014-07. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02206620?
The interventions under investigation include: Donepezil (DRUG).
Who is sponsoring clinical trial NCT02206620?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02206620's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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