临床试验/NCT01152216

NCT01152216终止3 期

An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease

Medivation, Inc.0 个研究点目标入组 672 人开始时间: 2010年4月最近更新: 2016年9月27日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方: Medivation, Inc.
入组人数: 672
主要终点: Safety

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

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Successful completion of the 12 month DIM18 CONCERT study
•Mild-to-moderate Alzheimer's disease
•Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
•Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive
•Stable on donepezil for at least 6 months

排除标准

•Other causes of dementia
•Major structural brain disease
•Unstable medical condition or significant hepatic or renal disease

研究组 & 干预措施

Dimebon

Experimental

干预措施: Dimebon (Drug)

结局指标

主要结局

Safety

时间窗: Through study discontinuation

To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.

次要结局

未报告次要终点

研究者

发起方

Medivation, Inc.

申办方类型

Industry

责任方

Sponsor

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