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NCT00934375 · ClinicalTrials.gov registry record · Phase 4
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
A Phase 4 study of Mild Cognitive Impairment, sponsored by Eisai.
- Completed
- Registry status
- Phase 4
- Development phase
- 145
- Enrollment target
- 20
- Study locations
NCT00934375: Completed Phase 4 study of Mild Cognitive Impairment, sponsored by Eisai.
NCT00934375 is a Phase 4 study of Mild Cognitive Impairment that has completed, run by Eisai. The registered enrollment target is 145 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00934375, a Phase 4 study of Mild Cognitive Impairment, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 145 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
Primary Outcome
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Conditions Studied
Interventions
- DRUG placebo
- DRUG Aricept (donepezil hydrochloride)
Study Locations (20)
California
- The Neurology Center - Encinitas
- Margolin Brain Institute - Fresno
- Colaborative Neuroscience Network (CNS Network) - Garden Grove
- Nerve Pro Research - Irvine
- Optimum Health Services - La Mesa
- Pacific Research Network - San Diego
- Neurological Research Institute - Santa Monica
- CA Neuroscience Research - Sherman Oaks
- Pacific Research Network - Vista
Florida
- North Broward Medical Center Memory Disorder Center - Deerfield Beach
- Neurologic Consultants - Fort Lauderdale
- Berma Research Group - Hialeah
- Sunrise Clinical Research - Hollywood
- Wien Center for Memory Disorders, Mount Sinai Medical Center - Miami Beach
- Berma Research Group - Plantation
Arizona
- Pivotal Research Centers - Peoria
- Sun Health Research Institute - Sun City
- Northwest Neurospecialists, PLLC - Tucson
Alabama
- Neurology Neurodiagnostic Lab, LLC - Alabaster
Connecticut
- Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
What the finished NCT00934375 record still lists
NCT00934375 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00934375 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00934375 about?
NCT00934375 is a clinical study titled "A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment". This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
What is the current status of trial NCT00934375?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 145 participants. The study started on 2006-02. Estimated completion is 2007-09.
What conditions does trial NCT00934375 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment.
What interventions are being tested in trial NCT00934375?
The interventions under investigation include: placebo (DRUG), Aricept (donepezil hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT00934375?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00934375 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00934375's enrollment target sits among peer trials
145 69th of 205 higher than 136 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment 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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