NCT00481520已完成2 期
A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects With Mild to Moderate Alzheimer's Disease.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 72 人开始时间: 2007年6月最近更新:
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
- 72
- 主要终点
- Routine safety and tolerability will be evaluated.
研究概览
简要总结
The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: SAM-531 (Drug)
2
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Routine safety and tolerability will be evaluated.
时间窗: 28 days
次要结局
- This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.(28 days)
研究者
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