NCT03456349已完成1 期
A Phase 1b Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment emergent adverse events (TEAEs), Safety and Tolerability
研究概览
简要总结
Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care
详细描述
This is a multi-centre study conducted in four countries. A total of 60 subjects with Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active HTL0018318 or placebo for a period of four weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria
- •Participants with Alzheimer's disease on stable standard of care
排除标准
- •Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction
- •A current or history of clinically significant suicidal ideation within the past 6 months
- •Subjects who have been on anti-cholinergic and/or anti muscarinic treatment
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Low dose
Experimental
HTL0018318
干预措施: HTL0018318 (Drug)
Medium dose
Experimental
HTL0018318
干预措施: HTL0018318 (Drug)
High dose
Experimental
HTL0018318
干预措施: HTL0018318 (Drug)
结局指标
主要结局
Treatment emergent adverse events (TEAEs), Safety and Tolerability
时间窗: Baseline to Day 28
次要结局
未报告次要终点
研究者
研究点 (1)
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