NCT01093664已完成1 期
Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in AFF002 and AFF004
排除标准
- •Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
- •Contraindication for MRI imaging
- •History and/or presence of autoimmune disease, if considered relevant by the investigator
- •Active infectious disease (e.g., Hepatitis B, C)
- •Presence and/or history of Immunodeficiency (e.g., HIV)
- •Significant systemic illness
结局指标
主要结局
Safety and Tolerability
时间窗: July 2010
* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Adverse events (AEs) * Serious adverse events (SAEs) * Physical and neurological examination * Concomitant medication * Vital signs (blood pressure, heart rate, respiratory rate, body temperature) * Body mass (weight and height) * MRI of brain * ECG * Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)
次要结局
- Immunological and clinical activity(July 2010)
研究者
研究点 (2)
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