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NCT00566501 · ClinicalTrials.gov registry record · Phase 3

Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease

A Phase 3 study of Alzheimers Disease, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
915
Enrollment target
1
Study location

NCT00566501 is a Phase 3 study of Alzheimers Disease that has completed, run by Eisai. The registered enrollment target is 915 participants, below the 4,055-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00566501, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
915 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.

Conditions Studied

Interventions

  • DRUG Donepezil

Study Locations (1)

California

  • Apex Research Institute - Santa Ana

Trial Details

FieldValue
Enrollment Target 915 participants
Start Date 2007-12-14
Est. Completion 2010-04-01
Phase Phase 3

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT00566501

The ClinicalTrials.gov registry entry for NCT00566501 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 915 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,055-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (77% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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

NCT00566501 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00566501 about?

NCT00566501 is a clinical study titled "Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease". The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse...

What is the current status of trial NCT00566501?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 915 participants. The study started on 2007-12-14. Estimated completion is 2010-04-01.

What conditions does trial NCT00566501 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT00566501?

The interventions under investigation include: Donepezil (DRUG).

Who is sponsoring clinical trial NCT00566501?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00566501 being conducted?

This trial has 1 study location across California. 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

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.