NCT00357357已完成2 期
Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
研究概览
简要总结
The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（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
Group1
Placebo Comparator
4x 7 day rising dose
干预措施: HF0220 (Drug)
Group2
Placebo Comparator
4x, 7 day rising dose
干预措施: HF0220 (Drug)
Group3
Placebo Comparator
28 day fixed lower dose
干预措施: HF0220 (Drug)
Group4
Placebo Comparator
28 day fixed upper dose
干预措施: HF0220 (Drug)
结局指标
主要结局
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
时间窗: June 2008
次要结局
- Validate biochemical markers relevant to Alzheimer's disease(June 2008)
- Assess the suitability of chosen HF0220 dose levels for future studies(June 2008)
研究者
研究点 (10)
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