A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Phase 3

Completed

• Conditions: Alzheimer's Type Dementia
• Interventions: Drug: Placebo; Drug: E2020

• Registration Number: NCT01404169
• Lead Sponsor: Eisai Limited

Brief Summary

The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-09
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	E2020	-

Primary Outcome Measures

Name	Time	Method
The change in the total Severe Impairment Battery (SIB) score at Week 24	24 weeks	All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.

Secondary Outcome Measures

Name	Time	Method
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24	24 weeks	An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.

Trial Locations

Locations (32)

Beijing Anding Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Huilongguan Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Guangzhou Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China

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