NCT00956410已完成2 期
An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
研究概览
简要总结
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed the Core study with no significant safety concerns
排除标准
- •Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
- •Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
- •diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
研究组 & 干预措施
CAD106
Experimental
干预措施: CAD106 (Biological)
结局指标
主要结局
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
时间窗: 66 weeks
次要结局
- Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.(66 weeks)
- Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66.(66 weeks)
- Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.(2 years)
研究者
研究点 (4)
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