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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 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 49 participants.
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.
Interventions
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02206620
The ClinicalTrials.gov registry entry for NCT02206620 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Donepezil is the first listed.
NCT02206620 reports 0 study locations.
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.
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