NCT00151333已完成2 期
A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.
Wyeth is now a wholly owned subsidiary of Pfizer3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease
研究概览
简要总结
To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 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
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 85 Years（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.
- •Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.
- •Able to give informed consent. Patient's caregiver must consent to participate in the study.
排除标准
- •Significant neurologic disease other than AD that may affect cognition.
- •Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.
- •Other exclusions apply
结局指标
主要结局
To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease
次要结局
- To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.
研究者
研究点 (3)
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