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A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
NCT00934375 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00934375
The ClinicalTrials.gov registry entry for NCT00934375 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00934375 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00934375?
The interventions under investigation include: placebo (DRUG), Aricept (donepezil hydrochloride) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00934375?
This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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