Donepezil to Treat Dementia in Parkinson's Disease
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating
mild dementia in patients with Parkinson's disease. Donepezil is approved for treating
patients with Alzheimer's disease, whose memory and cognition problems are similar to those
of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the
breakdown of a chemical messenger called acetylcholine, which is involved in memory and other
cognitive functions, and may improve cognition in patients.
Patients 40 years of age and older with Parkinson's disease who have mild to moderate
dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately
2 hours each, described below. Candidates will be screened for participation during Visit 1.
- Visit 1 (screening visit): Study candidates will have a medical history, physical and
neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will
also undergo neuropsychological testing (tests of memory, language, mood and, other
brain functions) and fill out a quality of life questionnaire. Those enrolled will be
randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike
pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased
to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5
mg. Those who do not tolerate the 5-mg dose will be taken off medication but will
continue to be followed and tested.
- Visit 2 (week 7): Patients will have a neurological examination and neuropsychological
testing and will fill out a quality of life questionnaire.
- Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will
stop taking the study medication.
- Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will
have their study medication switched. That is, patients previously on placebo will be
switched to donepezil, and patients who were taking donepezil will be switched to
placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day.
Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do
not tolerate the 5-mg dose will be taken off medication but will continue to be followed
and tested.
- Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit
2.
This study is being conducted at the National Institutes of Health, the University of
Pennsylvania, and Northwestern University
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)