NCT03668405终止1 期
Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Aβ-specific antibody titre in plasma
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lu AF20513 high dose
Experimental
干预措施: Lu AF20513 (Drug)
结局指标
主要结局
Aβ-specific antibody titre in plasma
时间窗: Baseline to week 96
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Baseline to week 96
Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans)
次要结局
未报告次要终点
研究者
研究点 (4)
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