Escitalopram for Agitation in Alzheimer's Disease
- Registration Number
- NCT03108846
- Lead Sponsor
- JHSPH Center for Clinical Trials
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 187
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1-3 capsules each containing placebo only once per day in the morning Escitalopram Escitalopram Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
- Primary Outcome Measures
Name Time Method modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) after 12 weeks Clinical Global Impression of Change
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (29)
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Biomedical Research Foundation
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California Los Angeles/VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
University of Southern California Keck School of Medicine Memory and Aging Center
🇺🇸Los Angeles, California, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Kansas School of Medicine-Wichita Center for Clinical Research
🇺🇸Wichita, Kansas, United States
Maryland VA Health Care System
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University School of Medicine, Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Alzheimer Disease Center
🇺🇸Quincy, Massachusetts, United States
Scroll for more (19 remaining)Banner Sun Health Research Institute🇺🇸Sun City, Arizona, United States