临床试验/NCT01539031

NCT01539031已完成3 期

Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to 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

Eisai Co., Ltd.0 个研究点目标入组 351 人开始时间: 2012年3月最近更新: 2023年6月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Eisai Co., Ltd.
入组人数: 351
主要终点: The Severe Impairment Battery (SIB)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

10 mg group

Experimental

干预措施: E2020 (Drug)

23 mg group

Active Comparator

干预措施: E2020 (Drug)

结局指标

主要结局

The Severe Impairment Battery (SIB)

时间窗: 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+)

时间窗: 24 weeks

CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)

次要结局

未报告次要终点

研究者

发起方

Eisai Co., Ltd.

申办方类型

Industry

责任方

Sponsor

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