NCT01225809已完成不适用
Observational Follow-up Extension Study-visit to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS001 in Patients With Alzheimer's Disease
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
- 17
- 试验地点
- 1
- 主要终点
- Long term tolerability and safety of AFFITOPE AD01
研究概览
简要总结
Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver.
- •Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01
- •Availability of a partner/caregiver knowing the patient
排除标准
- •Patients having received no vaccination with AFFITOPE AD01
- •History of questionable compliance to visit schedule
结局指标
主要结局
Long term tolerability and safety of AFFITOPE AD01
时间窗: One year.
retrospective assessment of safety data
次要结局
未报告次要终点
研究者
研究点 (1)
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