Escitalopram for Agitation in Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 187
- 试验地点
- 29
- 主要终点
- modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.
详细描述
This study is designed to examine the efficacy and safety of escitalopram as treatment for agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant agitation, and their caregiver(s), will receive a structured psychosocial intervention. Participants not showing a response three weeks later will be randomized 1:1 to escitalopram (up to 15 mg/day) or a matching placebo. Participants will receive study drug or placebo for 12 weeks, with in-person and remote (phone/video) visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person and remote visits. Participants who do show a response to the psychosocial intervention will not be randomized to study drug but will be followed remotely.
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
Over-encapsulation
入排标准
- 年龄范围
- 18 Years 至 109 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Escitalopram
Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
干预措施: Escitalopram (Drug)
Placebo
1-3 capsules each containing placebo only once per day in the morning
干预措施: Placebo (Drug)
结局指标
主要结局
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
时间窗: after 12 weeks
Clinical Global Impression of Change
次要结局
未报告次要终点
研究者
Dave Shade
Director, S-CitAD Coordinating Center
JHSPH Center for Clinical Trials