Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Phase 3

Completed

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

• Registration Number: NCT01539031
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2015-09
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg group	E2020	-
23 mg group	E2020	-

Primary Outcome Measures

Name	Time	Method
The Severe Impairment Battery (SIB)	24 weeks	SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)	24 weeks	CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)