Donepezil to Treat Dementia in Parkinson's Disease

NCT00030979 | Completed Phase 4

• 2 other identifiers: 02011502-N-0115
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson Disease

Keywords

Mild Dementia; Acetylcholine; Memory; Hallucinations; Washout; Parkinson Disease; Parkinson's Disease; PD; Dementia

Interventions

Donepezil DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 40.
• A clinical diagnosis of Idiopathic PD, stages I-IV, using British Brain Bank Research Diagnostic Criteria.
• Mild to moderate dementia with Mini Mental Status Score of 17-26.

You may not qualify if:

• The presence of an alternative cause of dementia such as AD or stroke, based on clinical evaluation. Subjects will have serologic screening for reversible causes of dementia, including syphilis, thyroid dysfunction and B12 deficiency.
• Presence of uncontrolled hallucinations-hallucinations that are disruptive such that they would interfere with cognitive testing.
• Patients with unstable or clinically significant medical problems such as cardiac arrhythmia or unstable heart disease (e.g. new onset angina) that would, in the judgment of the investigators, interfere with the safe conduct of the study.
• Patients enrolled in other protocols involving investigational drugs or surgery.
• Severe depression: Geriatric Depression Scale score greater than or equal to 13.
• Pregnancy or breast feeding.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kessler II. Epidemiologic studies of Parkinson's disease. 3. A community-based survey. Am J Epidemiol. 1972 Oct;96(4):242-54. doi: 10.1093/oxfordjournals.aje.a121455. No abstract available.

  PMID: 5074681 BACKGROUND

• 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 disease. Arch Neurol. 1988 Mar;45(3):260-2. doi: 10.1001/archneur.1988.00520270034017.

  PMID: 3341950 BACKGROUND

• Levin BE, Tomer R, Rey GJ. Cognitive impairments in Parkinson's disease. Neurol Clin. 1992 May;10(2):471-85.

  PMID: 1584185 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Hallucinations; Dementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 15, 2002
• First Posted: February 18, 2002
• Study Start: February 1, 2002
• Study Completion: March 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-03

Locations

US (1)