2023-504840-32-00招募中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 Squibb Services Unlimited Company13 个研究点 分布在 3 个国家入组 42 人开始时间: 2024年9月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 13
- 主要终点
- Change from baseline at Week 76 in brain tau deposition, as measured by tau positron emission tomography (PET)
研究概览
简要总结
To assess the effects of BMS-986446 vs placebo on brain tau deposition in Participants (age: 50 to 80) with early AD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
- Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
- Evidence of AD pathology.
- Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
- Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).
排除标准
- Any evidence of a condition that may affect cognition other than AD.
- Contraindications to PET imaging.
- Inability to tolerate or contraindication to magnetic resonance imaging.
- Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
- Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
结局指标
主要结局
Change from baseline at Week 76 in brain tau deposition, as measured by tau positron emission tomography (PET)
Change from baseline at Week 76 in brain tau deposition, as measured by tau positron emission tomography (PET)
次要结局
- Change from baseline at Week 76 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score
- Change from baseline at Week 76 in integrated Alzheimer’s Disease Rating Scale (iADRS) score
- Change from baseline at Week 76 in Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS- Cog14) score
- Change from baseline at Week 76 in Mini Mental State Examination (MMSE) score
- Change from baseline at Week 76 in Alzheimer’s Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (13)
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标识符
- 欧盟试验编号
- 2023-504840-32-00
- 其他研究编号
- CN008-0003, NCT06268886
日期
- 首次发布
- (2年前)
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
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