NCT06736509终止3 期
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 139
- 试验地点
- 22
- 主要终点
- Long-Term Safety
研究概览
简要总结
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
详细描述
This was a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that continued to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) or ACCORD-2 (AXS-05-AD-303).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
- •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-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.
研究组 & 干预措施
Open-Label
Experimental
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
干预措施: AXS-05 (dextromethorphan-bupropion) (Drug)
结局指标
主要结局
Long-Term Safety
时间窗: Up to 25 weeks
Incidence of treatment-emergent adverse events following dosing with AXS-05
次要结局
未报告次要终点
研究者
研究点 (22)
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