NCT00937352终止3 期
A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.
JANSSEN Alzheimer Immunotherapy Research & Development, LLC188 个研究点 分布在 1 个国家目标入组 896 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 896
- 试验地点
- 188
- 主要终点
- Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.
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
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable AD
- •Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
- •Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
- •Caregiver able to attend all clinic visits with patient
排除标准
- •Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
- •Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
- •Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
研究组 & 干预措施
Bapineuzumab 0.5 mg/kg
Active Comparator
0.5 mg/kg
干预措施: Bapineuzumab (Drug)
Bapineuzumab 1.0 mg/kg
Active Comparator
1.0 mg/kg
干预措施: Bapineuzumab (Drug)
结局指标
主要结局
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
时间窗: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
次要结局
- To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.(The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first)
研究者
研究点 (188)
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