NIH Clinical Research Studies

Protocol Number: 02-N-0115

Active Followup, Protocols NOT Recruiting New Patients

Title:
Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial
Number:
02-N-0115
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

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Follow-up Of Previously Enrolled Subjects Only
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions: Currently Not Provided
Disease Category:
PROTICD
Keywords:
Mild Dementia
Acetylcholine
Memory
Hallucinations
Washout
Recruitment Keywords:
Parkinson Disease
Parkinson's Disease
PD
Dementia
Conditions:
Parkinson Disease
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:
Kessler II Epidemiologic studies of Parkinson's disease 3 A community-based surveyAm J Epidemiol 1972 Oct;96(4):242-54 No abstract availablePMID: 5074681

Mayeux R, Stern Y, Rosenstein R, Marder K, Hauser A, Cote L, Fahn S An estimate of the prevalence of dementia in idiopathic Parkinson's diseaseArch Neurol 1988 Mar;45(3):260-2PMID: 3341950

Levin BE, Tomer R, Rey GJ Cognitive impairments in Parkinson's diseaseNeurol Clin 1992 May;10(2):471-85 ReviewPMID: 1584185

Active Followup, Protocols NOT Recruiting New Patients

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