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

NCT00566501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2021-11-17

Study results available
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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

Interventions

DRUG

Donepezil

Donepezil SR 23 mg once daily orally.

Sponsors & Collaborators

  • Eisai Limited

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Jane Yardley, Ph.D · Eisai Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
91 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-14
Primary Completion
2010-04-01
Completion
2010-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566501 on ClinicalTrials.gov