A Pilot Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF)
研究概览
简要总结
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.
详细描述
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD. The primary endpoint is the change from the baseline CSF Amyloid beta oligomer concentration after dosing with CT1812 versus placebo. The change from baseline will be measured through a number of exploratory endpoints as indicated below. For each subject, the baseline CSF oligomer concentration will be computed as the average of the measurements from hours -4, -3, -2 and -1 and 0.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind for study site and participants
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active Treatment- CT1812 560 mg
干预措施: CT1812 (Drug)
Active Treatment- CT1812 280 mg
干预措施: CT1812 (Drug)
Active Treatment- CT1812 90 mg
干预措施: CT1812 (Drug)
Placebo Comparator - Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF)
时间窗: 48 hours
evidence of oligomer displacement as demonstrated by a clear rise in CSF oligomer concentration relative to baseline and placebo
次要结局
未报告次要终点