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

Eisai Limited32 sites in 1 country260 target enrollmentSeptember 2011

ConditionsAlzheimer's Type Dementia

InterventionsE2020 Placebo

DrugsE2020 Placebo

Overview

Phase: Phase 3
Intervention: E2020
Conditions: Alzheimer's Type Dementia
Sponsor: Eisai Limited
Enrollment: 260
Locations: 32
Primary Endpoint: The change in the total Severe Impairment Battery (SIB) score at Week 24
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

September 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: E2020

2

Intervention: Placebo

Outcomes

Primary Outcomes

The change in the total Severe Impairment Battery (SIB) score at Week 24

Time Frame: 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.