Eisai Clinical Trials

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

E2020-G000-326

Study Overview

E2020
donepezil
NCT00478205, 2006-004888-54
Jun 2007 - Jun 2009
Alzheimer's disease
1. Change From Baseline to Week 24 in SIB Total Score [Time Frame: Baseline and Week 24]

2. Overall Change From Baseline in Modified CIBIC+ to Week 24 [Time Frame: Baseline and Week 24]

  • Males and females 45 Years to 90 Years (Adult, Older Adult)

  • Completed

  • Phase 3

  • United States

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Schmitt FA, Saxton J, Ferris SH, Mackell J, Sun Y. Evaluation of an 8-item Severe Impairment Battery (SIB-8) vs. the full SIB in moderate to severe Alzheimer’s disease patients participating in a donepezil study. Int J Clin Pract. 2013 Oct;67(10):1050-6. doi: 10.1111/ijcp.12188.

Salloway S, Mintzer J, Cummings JL, Geldmacher D, Sun Y, Yardley J, Mackell J. Subgroup analysis of US and non-US patients in a global study of high-dose donepezil (23 mg) in moderate and severe Alzheimer’s disease. Am J Alzheimers Dis Other Demen. 2012 Sep;27(6):421-32. doi: 10.1177/1533317512454708.

Data Sharing

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CSDR Sharing is available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR