The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
5-15 mg/day (target: 15mg/day if tolerated)
Masked placebo
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
Clinical Global Impression of Change
Time frame: after 12 weeks
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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
...and 19 more locations