Phase 4
Completed N=21
The Effect of Donepezil on Gait and Balance in Parkinson's Disease
Source: ClinicalTrials.gov NCT01521117 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Sensory Organization Test - Composite Score — 7.7; 0.6 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and muscle rigidity. Current medications for the treatment of PD do not improve gait and balance difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The investigators study will look at what aspects of gait and balance are improved by the study drug. The study drug is not approved to treat PD in the United States or other countries because we do not know enough about it.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensory Organization Test - Composite Score |
7.7; 0.6 | — |
| PRIMARY Sensory Organization Test (SOT) - Condition 4 (Eyes Open, Moving Surround, Stable Platform). |
6.52; -0.89 | — |
| SECONDARY Trails B - A |
9.4; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn and Yahr score of 2 to 4
- Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for at least one month
- Abnormal computerized dynamic posturography (CDP) on screening defined as a composite score below 65 (range 1-100)
Exclusion Criteria
- Dementia defined by MMSE less than 27
- Other medical conditions other than PD affecting balance or gait as determined by the investigators
- Unable to stand unassisted for 30 minutes
- Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic properties
- Medical or psychiatric co-morbidities that may interfere with compliance or might place subject in danger as determined by the investigators
Data sourced from ClinicalTrials.gov (NCT01521117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.