Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 49
- 主要终点
- Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.
详细描述
This is a Phase 2/3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker.
The study will be conducted at up to 60 centers in the US, Canada and Europe.. 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. Approximately 100 patients per arm will be randomized (300 total).
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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.
- •A previously established diagnosis of AD dementia.
- •The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
- •The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
- •Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.
排除标准
- •The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
- •The participant has symptoms of agitation that are not secondary to AD dementia
- •The participant has a history of uncontrolled seizures or a history of epilepsy.
- •The participant has a major medical illness or unstable medical condition
研究组 & 干预措施
EXV-802
Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.
干预措施: EXV-802 (Drug)
Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.
干预措施: Placebo (Drug)
EXV-801
Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.
干预措施: EXV-801 (Drug)
结局指标
主要结局
Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score
时间窗: Baseline to Week 6
The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviors while lower scores indicate lower frequency of agitated behaviors The CMAI-IPA includes 19 items that were mapped to IPA agitation domains. The total score ranges from 19 to 133 with higher scores indicating more severity.
次要结局
- Changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to symptoms of agitation(Baseline to Week 6)