NCT00021723终止2 期
Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
JANSSEN Alzheimer Immunotherapy Research & Development, LLC20 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2001年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 375
- 试验地点
- 20
研究概览
简要总结
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.
详细描述
The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with 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
- •Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.
排除标准
- 未提供
研究者
研究点 (20)
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