NCT01568086终止不适用
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Affiris AG
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Safety/Tolerability
研究概览
简要总结
This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（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 the patient and the caregiver.
- •Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
- •Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls
排除标准
- •Patients having received no vaccination with AFFITOPE AD03
- •History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
结局指标
主要结局
Safety/Tolerability
时间窗: 52 weeks
* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Number and kind (description) of AEs * Number and kind (description) of SAEs * Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)
次要结局
- Immunological(52 weeks)
- Clinical Efficacy(52 weeks)
研究者
研究点 (2)
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