NCT06268886进行中（未招募）2 期
A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)
Bristol-Myers Squibb176 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2024年3月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 310
- 试验地点
- 176
- 主要终点
- Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
研究概览
简要总结
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.
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)
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
Placebo
Placebo Comparator
干预措施: Placebo (Other)
BMS-986446 Dose A
Experimental
干预措施: BMS-986446 (Drug)
BMS-986446 Dose B
Experimental
干预措施: BMS-986446 (Drug)
结局指标
主要结局
Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
时间窗: At week 76
次要结局
- Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score(At week 76)
- Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score(At week 76)
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score(At week 76)
- Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score(At week 76)
- Change from baseline in Mini Mental State Examination (MMSE) score(At week 76)
研究者
研究点 (176)
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