A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 375
- 试验地点
- 104
- 主要终点
- Cohen-Mansfield Agitation Inventory (CMAI)
研究概览
简要总结
This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.
Approximately 375 participants will be enrolled at approximately 50 centers worldwide.
Study medication will be administered orally once-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
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
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- •Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.
- •Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).
排除标准
- •Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)
- •Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- •Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.
研究组 & 干预措施
High Dose Masupirdine Arm
Tablet
干预措施: Masupirdine 100 mg (Drug)
Low Dose Masupirdine Arm
Tablet
干预措施: Masupirdine 50 mg (Drug)
Placebo
Tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Cohen-Mansfield Agitation Inventory (CMAI)
时间窗: From Baseline to Week 12 visit
Change in CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains (physical aggression, excessive motor activity, and verbal aggression). CMAI is a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate worsening agitation.
次要结局
- Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)(From Baseline to Week 12 visit)