NCT00471211已完成2 期
A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease
Prana Biotechnology Limited15 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2006年12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
- 80
- 试验地点
- 15
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.
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
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of probable early Alzheimer's disease
- •stable dose of acetylcholinesterase inhibitor
- •community dwelling
- •stable medical condition
排除标准
- •unstable and significant medical conditions
- •recurrent major psychiatric disorder
- •treatment with memantine
结局指标
主要结局
Safety
时间窗: Study duration
次要结局
- Change from baseline in biomarkers; Change from baseline in cognitive and global function scales(Study duration)
研究者
研究点 (15)
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