NCT00277810已完成2 期
A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of 3 Doses of Lecozotan (SRA-333) SR in Outpatients With Mild to Moderate Alzheimer's Disease Treated With a Cholinesterase Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 250
- 主要终点
- All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (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
- Triple (Participant, Care Provider, Investigator)
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
- •Current use of cholinesterase inhibitor
- •Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study
排除标准
- •Significant neurological disease other than AD
- •Diagnosis of major depression
- •History of stroke or other heart disease
研究组 & 干预措施
A
Experimental
干预措施: lecozotan SR (SRA-333) (Drug)
B
Experimental
干预措施: lecozotan SR (SRA-333) (Drug)
C
Experimental
干预措施: lecozotan SR (SRA-333) (Drug)
结局指标
主要结局
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
时间窗: 6 mo extension study: week 24
次要结局
- Score change from baseline to 24 weeks on functional and behavioral scales(week 24)
研究者
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