NCT00380302已完成1 期
A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Safety and tolerability throughout the study:adverse events collected by spontaneous report
研究概览
简要总结
Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).
Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of Alzheimer's disease
- •Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI)
- •Mild to moderate range of disease; not too severe
排除标准
- •Severe or unstable medical diseases
- •Neurological disorder other than Alzheimer's disease
- •Depression that is not well controlled
- •Treatment with memantine
- •Inpatient in a total care facility (e.g.: Nursing home)
- •Lack of reliable caregiver
结局指标
主要结局
Safety and tolerability throughout the study:adverse events collected by spontaneous report
physical examination and neurological assessment
vital sign monitoring, clinical laboratories, and ECGs.
Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.
次要结局
- Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
研究者
研究点 (5)
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