Escitalopram for Agitation in Alzheimer's Disease

(S-CitAD Trial)

Recruiting at 34 trial locations

Overseen By Douglas Scharre, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: JHSPH Center for Clinical Trials

Must be taking: Antipsychotics

Must not be taking: Antidepressants, Benzodiazepines, Psychostimulants

Disqualifiers: Major depression, Other brain diseases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

187 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Constantine Lyketsos, MD, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Psychosocial Intervention

Participants and their caregivers receive a structured psychosocial intervention

3 weeks

1 visit (in-person)

Treatment

Participants receive escitalopram or placebo for 12 weeks

12 weeks

4 visits (in-person/remote) at weeks 3, 6, 9, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Escitalopram

Trial Overview The 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.

How Is the Trial Designed?

Group I: Escitalopram Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Escitalopram is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder

Approved in European Union as Cipralex for:

• Major depressive episodes
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder with or without agoraphobia
• Obsessive-compulsive disorder

Approved in Canada as Cipralex for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder

Who Is Running the Clinical Trial?

JHSPH Center for Clinical Trials

Lead Sponsor

Trials

14

Recruited

11,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+