NCT00104013已完成3 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,455
- 试验地点
- 73
- 主要终点
- Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
研究概览
简要总结
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).
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
- Double
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
- •Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
- •Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
- •Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period
- •Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
- •Mother tongue is English, Spanish or French (oral and written fluency)
- •Signed informed consent from potential participant or legal representative and identified caregiver
排除标准
- •Potential participant with any other cause of dementia.
- •Potential participant with serious health problems other than Alzheimer's disease
- •Use of an investigational drug within two months prior to randomization or during this study
结局指标
主要结局
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
次要结局
- Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
研究者
研究点 (73)
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