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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: Completed Phase 4 study of Parkinson Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG Donepezil
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2002-02 |
| Est. Completion | 2005-03 |
| Phase | Phase 4 |
What the finished NCT00030979 record still lists
NCT00030979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00030979's enrollment target sits among peer trials
28 219th of 297 higher than 78 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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