Escitalopram for Agitation in Alzheimer's Disease

Dementia Clinical Trial

— S-CitAD  

Official title:

Escitalopram for Agitation in Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108846
• Other study ID #: S-CitAD
• Secondary ID: R01AG052510
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 3, 2018
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: JHSPH Center for Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 187
• Est. completion date: May 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 109 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• Escitalopram
5-15 mg/day (target: 15mg/day if tolerated)
• Placebo
Masked placebo

Locations

Country	Name	City	State
Canada	University of Calgary and Foothills Medical Centre	Calgary	Alberta
Canada	Lawson Health Research Institute/Parkwood Institute	London	Ontario
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	Centre for Memory and Aging	Toronto	Ontario
Canada	Neuropsychopharmacology Research Group, Sunnybrook	Toronto	Ontario
Canada	Unity Health	Toronto	Ontario
Canada	Ontario Shores	Whitby	Ontario
United States	Abington Neurological Associates, Ltd	Abington	Pennsylvania
United States	Johns Hopkins University School of Medicine, Bayview Medical Center	Baltimore	Maryland
United States	Maryland VA Health Care System	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	University of Virginia Adult Neurology	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	Baylor AT&T Memory Center	Dallas	Texas
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	Biomedical Research Foundation	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of California Los Angeles/VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	University of Southern California Keck School of Medicine Memory and Aging Center	Los Angeles	California
United States	Miami Jewish Health Systems	Miami	Florida
United States	Columbia University	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Alzheimer Disease Research Center; University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Alzheimer Disease Center	Quincy	Massachusetts
United States	University of Rochester Medical Center	Rochester	New York
United States	UT Health San Antonio	San Antonio	Texas
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Kansas School of Medicine-Wichita Center for Clinical Research	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
JHSPH Center for Clinical Trials	National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC)	Clinical Global Impression of Change	after 12 weeks