NCT00602680终止2 期
A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in cognitive performance
研究概览
简要总结
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.
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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with diagnosis of mild AD
排除标准
- •Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
- •Medical condition which may interfere with the study
- •History of epileptic seizures
- •Lens opacity
- •Lack of reliable caregiver
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
dose 1
干预措施: SSR180711C (Drug)
2
Experimental
dose 2
干预措施: SSR180711C (Drug)
3
Experimental
dose 3
干预措施: SSR180711C (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
5
Active Comparator
干预措施: donepezil (Drug)
结局指标
主要结局
Change in cognitive performance
时间窗: 4 weeks
次要结局
- Cognitive, global, functional and behaviorial assessments(4 weeks)
研究者
研究点 (1)
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