NCT01254773已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects With Mild to Moderate Alzheimer's Disease
JANSSEN Alzheimer Immunotherapy Research & Development, LLC1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.
研究概览
简要总结
This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.
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 89 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 18-26 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
- •Amyloid burden on screening PET scan consistent with diagnosis of AD
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 SC Dose 1; 2 mg
Experimental
干预措施: Experimental Bapineuzumab (Drug)
Bapineuzumab SC Dose 2; 7 mg
Experimental
干预措施: Experimental Bapineuzumab (Drug)
Bapineuzumab SC Dose 3; 20 mg
Experimental
干预措施: Experimental Bapineuzumab (Drug)
结局指标
主要结局
To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.
时间窗: 24 months
次要结局
- To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.(24 months)
- To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD(24 months)
研究者
研究点 (1)
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