NCT00087724终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 510
- 试验地点
- 86
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject satisfies the criteria for the clinical diagnosis of probable AD
- •Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit
排除标准
- •Subject has history or evidence of significant neurologic disease other than AD
- •Subject has a history of stroke
- •Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years
- •Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry
- •Subject has medically unstable COPD or asthma
- •Subject has end stage CHF (NYHA Class III or IV) or unstable angina
- •Subject has evidence of significant renal insufficiency
- •Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening
研究者
研究点 (86)
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