N/A
N=23
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00912808 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Fall Frequency Per Day — 0.13; 0.25 Number Falls/Day — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Donepezil (Drug); Sugar Pill (placebo) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fall Frequency Per Day |
0.13; 0.25 | 0.049 sig |
| SECONDARY Frequency of Near Falls Per Day |
2.50; 2.04 | 0.27 |
Summary
The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.
Eligibility Criteria
Inclusion Criteria
- Age over 21
- Diagnosis of Parkinson's disease
- Treated with dopaminergic medication for at least 1 year
Exclusion Criteria
- Must be ambulatory (can use walker or cane)
- No obvious remediable cause of falls
- Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)
- Dementia present (MMSE < 25)
- Not taking cholinergic or anticholinergic medications 10 days prior to screening visit
- No Warfarin use
Data sourced from ClinicalTrials.gov (NCT00912808). 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.