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

January 30, 2025 updated by: Dave Shade, JHSPH Center for Clinical Trials
The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary and Foothills Medical Centre
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Lawson Health Research Institute/Parkwood Institute
      • Toronto, Ontario, Canada, M6J1H4
        • Centre for Addiction and Mental Health
      • Toronto, Ontario, Canada, M5B 1W8
        • Unity Health
      • Toronto, Ontario, Canada, M4N 3M5
        • Neuropsychopharmacology Research Group, Sunnybrook
      • Toronto, Ontario, Canada
        • Centre for Memory and Aging
      • Whitby, Ontario, Canada, L1N 5S9
        • Ontario Shores
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Biomedical Research Foundation
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California Keck School of Medicine Memory and Aging Center
      • Los Angeles, California, United States, 90073
        • University of California Los Angeles/VA Greater Los Angeles Healthcare System
    • Florida
      • Miami, Florida, United States, 33137
        • Miami Jewish Health Systems
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Kansas School of Medicine-Wichita Center for Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Maryland VA Health Care System
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University School of Medicine, Bayview Medical Center
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Alzheimer Disease Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Health
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates, LTD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Alzheimer Disease Research Center; University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper St. Francis Healthcare
    • Texas
      • Dallas, Texas, United States, 75231
        • Baylor AT&T Memory Center
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Adult Neurology
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
  2. Mini-Mental State Examination Telephone (MMSET) score of 3-20 inclusive
  3. Meets the International Psychogeriatric Association (IPA) provisional criteria for agitation in cognitive disorders

  4. Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory (NPI) for which either:

    • The frequency is 'Very frequently,' or
    • The frequency is 'Frequently' AND the severity is 'Moderate' or 'Marked'
  5. Provision of informed consent for participation in the study by both caregiver and participant (or, if participant is unable to provide informed consent, with surrogate consent and participant assent)
  6. Availability of a caregiver who spends at least several hours per week with the participant, supervises his/her care, is willing to accompany the participant to study visits, and is willing to participate in the study
  7. Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
  8. A medication for agitation is appropriate, in the opinion of the study physician

Exclusion criteria

  1. Has major depression, as indicated by major depressive episode (MDE) in the past 90 days (meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria)
  2. 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)
  3. Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility
  4. 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
  5. Prior failed treatment attempt with citalopram or escitalopram for agitation after adequate trial, at minimally accepted dose
  6. Indication for psychiatric hospitalization or acute suicidality, in the opinion of the study physician
  7. Recent (< 7 days) changes in antipsychotics, anticonvulsants, or psychosis (delusions or hallucinations) requiring a new or change in antipsychotic treatment (in the opinion of the study physician)
  8. Abnormal corrected QT interval using Bazett's formula (QTcB)** as determined on enrollment ECG (defined as > 450 ms for men and > 470 ms for women)
  9. Recent (30 days) presence of severely reduced renal function (as identified by a Glomerular filtration rate (GFR) clearance < 30 mL/min) or reduced hepatic function

  10. Current treatment (within 7 days) with any of the following:

    • antidepressants (other than trazodone, ≤ 100 mg per day at bedtime)
    • benzodiazepines (other than lorazepam), or
    • psychostimulants
  11. Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
  12. Recent (< 14 days) use of medical marijuana
  13. Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
  14. Significant communicative impairments that would affect participation in a clinical trial

  15. Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the potential participant to enroll in the trial

    • if the QTcB is determined while the rhythm is paced, 50 ms is subtracted from the calculated value. The study cardiologist must confirm eligibility in this scenario.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Escitalopram
Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
Drug: Escitalopram
5-15 mg/day (target: 15mg/day if tolerated)
Other Names:
  • Lexapro
Placebo Comparator: Placebo
1-3 capsules each containing placebo only once per day in the morning
Drug: Placebo
Masked placebo
Other Names:
  • non-applicable

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)
Time Frame: after 12 weeks
Clinical Global Impression of Change
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JHSPH Center for Clinical Trials

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Constantine Lyketsos, MD, MHS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-CitAD
  • R01AG052510 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Escitalopram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings