NCT00174525Unknown2 期
A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
Pharmacology Research Institute3 个研究点 分布在 1 个国家开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 3
- 主要终点
- Safety assessments
研究概览
简要总结
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
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
- •Diagnosis of probable AD
- •Age from 50 to 85 years, inclusive
- •Rosen Modified Hachinski ischemic score less than or equal to 4
- •Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
- •Fluency in English
- •Stable doses of medications
排除标准
- •Significant neurological disease other than AD
- •Major psychiatric disorder
- •Significant systemic illness
- •History of stroke or seizure
- •Weight greater than 120kg (264 lbs.)
- •History of autoimmune disease
- •Smoking more than 20 cigarettes per day
- •Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
- •Prior treatment with experimental immunotherapeutics or vaccines for AD
- •Presence of pacemakers or foreign metal objects in the eyes, skin, or body
结局指标
主要结局
Safety assessments
次要结局
- Blood levels of administered study drug
- Cognitive and functional assessments
研究者
研究点 (3)
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