drugset / Trial / NCT00566501

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

NCT00566501

Phase 3 Completed 915 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-12-14
Primary completion
2010-04-01
Completion
2010-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 23 mg Oral

Indications