Escitalopram for Agitation in Alzheimer's Disease
(S-CitAD Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: JHSPH Center for Clinical Trials

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.

Research Team

Constantine Lyketsos, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with Alzheimer's dementia experiencing frequent and severe agitation/aggression. Participants must be diagnosed by NIA/AA criteria, have a caregiver, and if using antipsychotics, the dosage should be stable. Excluded are those with major depression recently, residing in certain care facilities, recent medication changes that affect the brain or heart function issues.

Inclusion Criteria

You scored between 3 and 20 on the Mini-Mental State Examination Telephone (MMSET).

You have frequent and moderate to severe agitation or aggression based on a specific assessment.

I have a caregiver willing to support me during the study.

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Exclusion Criteria

Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility

You have been recently hospitalized for a mental health condition or are currently having strong thoughts of harming yourself, according to the study doctor's opinion.

I am not currently taking certain antidepressants, benzodiazepines, or psychostimulants.

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Treatment Details

Interventions

Escitalopram (Selective Serotonin Reuptake Inhibitor)

Trial OverviewThe study tests escitalopram's safety and effectiveness against placebo for reducing agitation in Alzheimer's patients. Participants will either receive escitalopram or a placebo to compare outcomes between the two groups.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EscitalopramExperimental Treatment1 Intervention

Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning

Group II: PlaceboPlacebo Group1 Intervention

1-3 capsules each containing placebo only once per day in the morning

Escitalopram is already approved in Canada for the following indications: