CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,467 enrolled
Drug / intervention
Aricept (donepezil SR 23 mg) +1 moredrug
Likely dose
Aricept (donepezil SR 23 mg)from 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.

Search/NCT00478205
NCT00478205Phase 3Completed
CompareCT.gov

Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease

Eisai Inc.·interventional·Posted May 24, 2007·Updated Jul 11, 2014

In Brief

A Phase 3 clinical trial evaluating Aricept (donepezil SR 23 mg) and Aricept (donepezil IR 10 mg) for Alzheimer's Disease. Completed, enrolled 1,467 participants across 1 site.

Detailed Summary

The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsEisai Limited

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2007
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.1 years ago

Interventions

Aricept (donepezil SR 23 mg)drug

Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation.

Aricept (donepezil IR 10 mg)drug

Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.