A Phase 1B Multiple Ascending Dose Study of The Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Stage 1 and Stage 2 Incidence of clinically significant lab abnormalities
研究概览
简要总结
A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients with Alzheimer's Disease
详细描述
This double-blind placebo-controlled study will be completed in 2 stages. The first stage will evaluate 10-days of BID dosing in four ascending dose cohorts in healthy older adults and Stage 2 will examine BMS-984923 dosed BID for 28 days at two dose levels in comparison to Placebo in participants with early AD.
This research study will assess the safety and tolerability of multiple doses of BMS-984923 for the treatment of early Alzheimer's Disease (AD) and investigate the use of synaptic density, measured with positron emission tomography (PET), as an early marker of therapeutic response to treatments that target synapse restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Placebo capsules
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
50 mg active
BMS-984923 50 mg in healthy participants
干预措施: BMS-984923 (Drug)
50 mg Placebo
Placebo 50 mg in healthy participants
干预措施: Placebo (Drug)
100 mg Active
BMS-984923 100 mg in healthy participants
干预措施: BMS-984923 (Drug)
100 mg Placebo
Placebo 100 mg in healthy participants
干预措施: Placebo (Drug)
100 mg Active 20d
BMS-984923 100 mg in healthy participants 20 days
干预措施: BMS-984923 (Drug)
100 mg Placebo 20d
Placebo 100 mg in healthy participants 20 days
干预措施: Placebo (Drug)
150 mg Active 20d
BMS-984923 150 mg in healthy participants 20 days
干预措施: BMS-984923 (Drug)
150 mg Placebo 20d
Placebo 150 mg in healthy participants 20 days
干预措施: Placebo (Drug)
50 mg Active-AD
BMS-984923 50 mg
干预措施: BMS-984923 (Drug)
100 mg Active-AD
BMS-984923 100 mg
干预措施: BMS-984923 (Drug)
Placebo-AD
Placebo matching
干预措施: Placebo (Drug)
结局指标
主要结局
Stage 1 and Stage 2 Incidence of clinically significant lab abnormalities
时间窗: Up to 10 days after last dose
Safety
Stage 1 and Stage 2 Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 10 days after last dose
Safety
Stage 1 Incidence of clinically significant changes in safety assessments
时间窗: Up to 10 days after last dose
Vital signs, physical exam, electrocardiogram \[ECG\], Neuropsychiatric Inventory-Questionnaire \[NPI Q\], Geriatric Depression Scale \[GDS\], Glasgow Coma Scale \[GCS\], Montreal Cognitive Assessment \[MOCA\])
Stage 2 Incidence of clinically significant changes in safety assessments
时间窗: Up to 10 days after last dose
Vital signs, physical exam, ECG, NPI Q, GDS, MOCA, and Functional Assessment Questionnaire \[FAQ\])
次要结局
- Stage 1 and Stage 2 Trough plasma drug concentration at steady state(Up to 10 days after last dose)
- Stage 1 and Stage 2 Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by PK modeling(Up to 10 days after last dose)
- Stage 2 Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale 14 Score range of 0-90, with higher scores indicating greater cognitive impairment.(Up to 7 days after the last dose)
- Stage 2 Change from baseline in synaptic density PET(Up to 24 hours after last dose)