An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Long-term Safety
研究概览
简要总结
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
详细描述
This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in Study AXS-05-AD-302 or Study AXS-05-AD-
- •Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.
排除标准
- •Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- •Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
- •Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
- •Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.
研究组 & 干预措施
AXS-05 (dextromethorphan-bupropion)
- Up to 52 weeks in the open-label segment;
- Up to 24 weeks in the randomized double-blind segment (if applicable)
干预措施: AXS-05 (dextromethorphan-bupropion) (Drug)
Placebo
Up to 24 weeks in the randomized double-blind segment (if applicable)
干预措施: Placebo (Drug)
结局指标
主要结局
Long-term Safety
时间窗: up to 76 weeks
Incidence of treatment-emergent adverse events following dosing with AXS-05
Time to relapse of agitation symptoms
时间窗: up to 24 weeks
次要结局
未报告次要终点