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NCT00478205 · ClinicalTrials.gov registry record · Phase 3
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
A Phase 3 study of Alzheimers Disease, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,467
- Enrollment target
- 1
- Study location
NCT00478205: Completed Phase 3 study of Alzheimers Disease, sponsored by Eisai.
NCT00478205 is a Phase 3 study of Alzheimers Disease that has completed, run by Eisai. The registered enrollment target is 1,467 participants, below the 3,916-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00478205, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,467 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.
Primary Outcome
The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.
Conditions Studied
Interventions
- DRUG Aricept (donepezil SR 23 mg)
- DRUG Aricept (donepezil IR 10 mg)
Study Locations (1)
North Carolina
- MedTrials, Inc. - Hickory
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,467 participants |
| Start Date | 2007-06 |
| Phase | Phase 3 |
What the finished NCT00478205 record still lists
NCT00478205 is an interventional study that assigns participants to a tested intervention. Its 1,467 participants enrollment target places it among the larger protocols in the corpus, below the 3,916-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Aricept (donepezil SR 23 mg) is the first listed.
NCT00478205 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00478205 about?
NCT00478205 is a clinical study titled "Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease". The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.
What is the current status of trial NCT00478205?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,467 participants. The study started on 2007-06.
What conditions does trial NCT00478205 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT00478205?
The interventions under investigation include: Aricept (donepezil SR 23 mg) (DRUG), Aricept (donepezil IR 10 mg) (DRUG).
Who is sponsoring clinical trial NCT00478205?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00478205 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
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 NCT00478205's enrollment target sits among peer trials
1,467 10th of 147 higher than 138 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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