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
2017年3月7日 更新者：Eisai Limited
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.
研究概览
研究类型
介入性
注册 (实际的)
260
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Nanchang、中国
- The Second Affiliated Hospital to Nanchang University
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Nanjing Jiangsu、中国
- Nanjing Brain Hospital
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Tianjin、中国
- Tianjin People's Hospital
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Tianjin、中国
- Tianjin Anding Hospital
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Beijing
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Beijing、Beijing、中国
- Chinese PLA General Hospital
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Beijing、Beijing、中国
- Beijing Hospital
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Beijing、Beijing、中国
- Xuanwu Hospital Capital Medical University
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Beijing、Beijing、中国
- Beijing Huilongguan Hospital
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Beijing、Beijing、中国
- Beijing Anding Hospital
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Chongqing
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Chongqing、Chongqing、中国
- The First Affiliated Hospital of Chongqing Medical University
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Chongqing、Chongqing、中国
- The Second Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou、Guangdong、中国
- Guangzhou First People's Hospital
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Guangzhou、Guangdong、中国
- Guangzhou Brain Hospital
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Guangxi
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Nanning、Guangxi、中国
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Hubei
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Wuhan、Hubei、中国
- Tongji Hospital, Tongji Medical College of HUST
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Wuhan、Hubei、中国
- Union Hospital, Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha、Hunan、中国
- The Third XIANGYA Hospital of Central South University
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Yueyang、Hunan、中国
- The First People's Hospital of Yueyang
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Shandong
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Jinan、Shandong、中国
- Qilu Hospital of Shandong University
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Jinan、Shandong、中国
- The Second Hospital of Shandong University
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Qingdao、Shandong、中国
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai、Shanghai、中国
- Shanghai Ruijin Hospital
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Shanghai、Shanghai、中国
- Shanghai Changzheng Hospital
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Shanghai、Shanghai、中国
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai、Shanghai、中国
- Hushan Hospital affliated to Fudan University
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Shanxi
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Xi'An、Shanxi、中国
- Tangdu Hospital, The Fourth Military Medical University
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Xi'An、Shanxi、中国
- Xi'an Mental Health Center
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Xi'An、Shanxi、中国
- Xijing Hospital, The Fourth Military Medical University
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Sichuan
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Chengdu、Sichuan、中国
- West China Hospital, Sichuan University
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Chengdu、Sichuan、中国
- Sichuan Provincial People's Hospital
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Yunnan
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Kunming、Yunnan、中国
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou、Zhejiang、中国
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria
- Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
- Subject age range: male and female subjects 50 to 90 years of age, inclusive
- Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- MMSE 1 to 12 inclusive, at both Screening and Baseline
- SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
- Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.
Exclusion Criteria
- Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
- Evidence of focal disease to account for dementia on any cranial image MRI or CT.
- Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
- Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
- Illiteracy prior to AD
- Subjects who are unwilling or unable to fulfill the requirements of the study
- Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
- Subjects with a poor response (tolerability) to prior exposure to donepezil
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1个
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In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
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安慰剂比较：2个
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Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The change in the total Severe Impairment Battery (SIB) score at Week 24
大体时间：24 weeks
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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.
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24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
大体时间：24 weeks
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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.
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24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Naoki Kubota、Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年9月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2011年7月26日
首先提交符合 QC 标准的
2011年7月26日
首次发布 (估计)
2011年7月27日
研究记录更新
最后更新发布 (实际的)
2017年3月8日
上次提交的符合 QC 标准的更新
2017年3月7日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.