Eisai Clinical Trials

A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

E2020-J081-231

Study Overview

E2020
donepezil
NCT00165659
Nov 2002 - May 2005
Alzheimer's disease
To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus (for overall evalution of clinical symtoms) and SIB (for cognitive function test) as the primary efficacy measures.

  • Males and females (age 50 years and over)

  • Completed

  • Phase 2

  • Japan

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Homma A, Imai Y, Tago H, Asada T, Shigeta M, Iwamoto T, et al. Donepezil treatment of patients with severe Alzheimer’s disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dement Geriatr Cogn Disord. 2008;25:399-407.

Data Sharing

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Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR