NCT00151398已完成2 期
A 3-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 With Donepezil As Active Control.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 229 人开始时间: 2005年10月6日最近更新:
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
- 入组人数
- 229
- 主要终点
- The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
研究概览
简要总结
The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
- •Able to give informed consent. Patient' s caregiver must consent to participate in the study.
排除标准
- •Use of medications for cognitive enhancement within 3 months of baseline.
- •Significant neurologic disease other than AD that may affect cognition.
研究组 & 干预措施
A
Experimental
干预措施: lecozotan SR (Drug)
B
Experimental
干预措施: lecozotan SR (Drug)
C
Experimental
干预措施: lecozotan SR (Drug)
D
Active Comparator
干预措施: Donepezil (Drug)
结局指标
主要结局
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
时间窗: weeks 12, 14, 26 and 40.
次要结局
- Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.(weeks 12, 14, 26 and 40.)
研究者
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