At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 915 enrolled
Drug / intervention
Donepezildrug
Likely dose
Donepezil 23 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Donepezil for Alzheimer's Disease. Completed, enrolled 915 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsEisai Limited
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2007
Enrollment StartDec 2007
Primary CompletionApr 2010
TodayJul 2026
First PostedDec 3, 2007
Enrollment StartDec 14, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago
Interventions
Donepezildrug
Donepezil SR 23 mg once daily orally.