NCT01023685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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 24
- 试验地点
- 16
- 主要终点
- Safety/tolerability assessments at multiple time points 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 investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
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
- 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.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety/tolerability assessments at multiple time points 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
- Immune response, cognitive and functional assessments at multiple time points 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 SAE's collection for two years after completion of the extension study.(2 years)
- Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.(66 weeks)
研究者
研究点 (16)
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