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Selective Serotonin Reuptake Inhibitor

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

Phase 3
Waitlist Available
Research Sponsored by JHSPH Center for Clinical Trials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
Be older than 18 years old
Must not have
Presence of another brain disease that fully explains the dementia, (e.g., extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
Contraindication to treatment with escitalopram as determined by a study physician, such as recent (30 days) use of monoamine oxidase inhibitors (MAOIs) or potential participant is hypersensitive to escitalopram or citalopram or any inactive ingredients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial will test whether the antidepressant escitalopram is effective and safe for treating agitation in Alzheimer's dementia.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleep disturbances, fatigue, dry mouth, increased sweating and could potentially worsen some psychiatric conditions such as depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My dementia is not caused by another brain disease like Parkinson's or MS.
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I am not allergic to escitalopram or citalopram, and haven't taken MAOIs in the last 30 days.
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I have trouble communicating, which may affect my participation in a study.
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I tried citalopram or escitalopram for agitation but it didn't work.
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I have been diagnosed with major depression in the last 3 months.
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My kidney or liver function is severely reduced recently.
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My heart's electrical activity is normal as per my latest ECG.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,191,930 Total Patients Enrolled
294 Trials studying Dementia
23,634,558 Patients Enrolled for Dementia
JHSPH Center for Clinical TrialsLead Sponsor
13 Previous Clinical Trials
11,055 Total Patients Enrolled
1 Trials studying Dementia
Constantine Lyketsos, MD, MHSStudy ChairJohns Hopkins University
2 Previous Clinical Trials
1,836 Total Patients Enrolled
1 Trials studying Dementia
1,650 Patients Enrolled for Dementia
~24 spots leftby Dec 2025
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