A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,121
- 试验地点
- 184
- 主要终点
- Cognitive and Functional
研究概览
简要总结
This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
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 88 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 less than 89
- •Mini-Mental Status Exam score of 16-26 inclusive
- •Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
- •Stable doses of medications (cholinesterase inhibitors and memantine allowed)
- •Caregiver able to attend all clinic visits with patient
排除标准
- •Significant neurological disease other than AD
- •Major psychiatric disorder
- •Significant systemic illness
- •History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
- •Smoking greater than 20 cigarettes per day
- •Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
- •Prior treatment experimental immunotherapeutics or vaccines for AD
- •Women of childbearing potential
- •Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
研究组 & 干预措施
Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
干预措施: Bapineuzumab 0.5 mg/kg (Drug)
Placebo Dose
infusion every 13 weeks for a total of 6 infusions.
干预措施: Placebo Control (Drug)
Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions.
干预措施: Bapineuzumab 1.0 m/kg (Drug)
结局指标
主要结局
Cognitive and Functional
时间窗: 18 months
次要结局
- Imaging and biochemical biomarkers of disease status(18 months)
- Cognitive and Global(18 months)