NCT03108846

Escitalopram for Agitation in Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 109 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia

Interventions

Type	Name	Description
DRUG	Escitalopram	5-15 mg/day (target: 15mg/day if tolerated)
DRUG	Placebo	Masked placebo

Timeline

• Start date: 2018-01-03
• Primary completion: 2024-04-05
• Completion: 2025-05-01
• First posted: 2017-04-11
• Last updated: 2025-01-31

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study