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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 25
- 主要终点
- safety assessments
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
详细描述
The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.
This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 120 kg (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
研究组 & 干预措施
2.0 mg/kg active bapineuzumab
干预措施: bapineuzumab (Drug)
2.0 mg/kg placebo
干预措施: placebo (Other)
0.15 mg/kg active bapineuzumab
干预措施: bapineuzumab (Drug)
0.15 mg/kg placebo
干预措施: placebo (Other)
0.5 mg/kg active bapineuzumab
干预措施: bapineuzumab (Drug)
0.5 mg/kg placebo
干预措施: placebo (Other)
1.0 mg/kg active bapineuzumab
干预措施: bapineuzumab (Drug)
1.0 mg/kg placebo
干预措施: placebo (Other)
结局指标
主要结局
safety assessments
时间窗: 18 months
次要结局
- blood levels of administered study drug(18 months)
- cognitive and functional assessments(18 months)