NCT00711321已完成不适用
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Long-term tolerability
研究概览
简要总结
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated by patient and caregiver
- •Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
- •Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
排除标准
- •Patients having received no vaccination with AFFITOPE AD02
- •History of questionable compliance to visit schedule, patients not expected to finish the clinical trial
结局指标
主要结局
Long-term tolerability
时间窗: 1 year
次要结局
- Clinical and immunological efficacy (evaluated in an explorative manner only)(1 year)
研究者
研究点 (1)
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