Escitalopram for Agitation in Alzheimer's Disease
Overview
- Phase
- Phase 3
- Intervention
- Escitalopram
- Conditions
- Dementia
- Sponsor
- JHSPH Center for Clinical Trials
- Enrollment
- 187
- Locations
- 29
- Primary Endpoint
- modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Dave Shade
Director, S-CitAD Coordinating Center
JHSPH Center for Clinical Trials
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Escitalopram
Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
Intervention: Escitalopram
Placebo
1-3 capsules each containing placebo only once per day in the morning
Intervention: Placebo
Outcomes
Primary Outcomes
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
Time Frame: after 12 weeks
Clinical Global Impression of Change