NCT06808984招募中2 期
A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Celgene
- 入组人数
- 120
- 试验地点
- 132
- 主要终点
- Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
研究概览
简要总结
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
- •The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
- •History of agitation with onset at least four weeks prior to Screening.
- •MMSE-1 score ≤
- •NPI-NH agitation/aggression sub-score ≥
- •Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).
- •Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.
排除标准
- •Clinically significant delusions/hallucinations requiring hospitalization.
- •History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- •History of major depressive episode with psychotic features during the 12 months prior to Screening.
- •History of delirium within 30 days of Screening.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BMS-986368 Dose 1
Experimental
干预措施: BMS-986368 (Drug)
BMS-986368 Dose 2
Experimental
干预措施: BMS-986368 (Drug)
结局指标
主要结局
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
时间窗: Up to Week 8
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.
次要结局
- Change in Clinical Global Impression-Severity (CGI-S)(Up to Week 8)
- Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score(Up to Week 8)
- CMAI sub-score change in Aggressive Behaviors(Up to Week 8)
- CMAI sub-score change in Physically Non-aggressive Behaviors(Up to Week 8)
- CMAI sub-score change in Verbally Agitated Behaviors(Up to Week 8)
- Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score(Up to Week 8)
- Change in NPI-NH Agitation/Aggression Domain Score(Up to Week 8)
- Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain(Up to Week 8)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Up to Day 28 After Last Dose)
- Number of Participants with Serious Adverse Events (SAEs)(Up to Day 28 After Last Dose)
- Number of Participants with Adverse Events (AEs)(Up to Day 28 After Last Dose)
- Number of Participants with Clinically Significant Laboratory Abnormalities(Up to 28 Days After Last Dose)
- Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)(Up to Day 28 After Last Dose)
- Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)(Up to Day 28 After Last Dose)
- Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)(Up to Day 21 After Last Dose)
- Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)(Up to Day 21 After Last Dose)
- Plasma Concentrations of BMS-986368(Up to Week 14)
研究者
研究点 (132)
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