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NCT00030979 · ClinicalTrials.gov registry record · Phase 4

Donepezil to Treat Dementia in Parkinson's Disease

A Phase 4 study of Parkinson Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 4
Development phase
28
Enrollment target
1
Study location

NCT00030979 is a Phase 4 study of Parkinson Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 28 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00030979, a Phase 4 study of Parkinson Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 4
Development phase
28 participants
Enrollment target
1
Study location

Study 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

Conditions Studied

Parkinson Disease

Interventions

  • DRUG Donepezil

Study Locations (1)

Maryland

  • National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2002-02
Est. Completion 2005-03
Phase Phase 4

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

567 total trials

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What the Registry Record Tells You About NCT00030979

The ClinicalTrials.gov registry entry for NCT00030979 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 1 intervention - of which Donepezil is the first listed.

NCT00030979 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00030979 about?

NCT00030979 is a clinical study titled "Donepezil to Treat Dementia in Parkinson's Disease". 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 di...

What is the current status of trial NCT00030979?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2002-02. Estimated completion is 2005-03.

What conditions does trial NCT00030979 study?

This clinical trial studies the following conditions: Parkinson Disease.

What interventions are being tested in trial NCT00030979?

The interventions under investigation include: Donepezil (DRUG).

Who is sponsoring clinical trial NCT00030979?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00030979 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.