Escitalopram for Agitation in Alzheimer's Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Dementia

In brief

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

Key facts

Study ID

NCT03108846

Run by

JHSPH Center for Clinical Trials

People needed

187

Starts

2018-01-03

Expected to finish

2025-05-01

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older, up to 109. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
• Mini-Mental State Examination Telephone (MMSET) score of 3-20 inclusive
• Meets the International Psychogeriatric Association (IPA) provisional criteria for agitation in cognitive disorders
• 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'
• 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)
• 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
• Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
• A medication for agitation is appropriate, in the opinion of the study physician

You may not qualify if…

• 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)
• 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)
• Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility
• 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
• Prior failed treatment attempt with citalopram or escitalopram for agitation after adequate trial, at minimally accepted dose
• Indication for psychiatric hospitalization or acute suicidality, in the opinion of the study physician
• 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)
• 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)
• 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
• 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
• Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
• Recent (< 14 days) use of medical marijuana
• Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
• Significant communicative impairments that would affect participation in a clinical trial
• 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.

Where it is running

• Banner Sun Health Research Institute — Sun City, Arizona, 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
• Kansas School of Medicine-Wichita Center for Clinical Research — Wichita, Kansas, United States
• Maryland VA Health Care System — Baltimore, Maryland, United States
• Johns Hopkins University School of Medicine, Bayview Medical Center — Baltimore, Maryland, United States
• Alzheimer Disease Center — Quincy, Massachusetts, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Abington Neurological Associates, Ltd — Abington, Pennsylvania, United States
• Alzheimer Disease Research Center; University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Roper St. Francis Healthcare — Charleston, South Carolina, United States
• Baylor AT&T Memory Center — Dallas, Texas, United States
• UT Health San Antonio — San Antonio, Texas, United States
• University of Virginia Adult Neurology — Charlottesville, Virginia, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• University of Calgary and Foothills Medical Centre — Calgary, Alberta, Canada
• Lawson Health Research Institute/Parkwood Institute — London, Ontario, Canada
• Neuropsychopharmacology Research Group, Sunnybrook — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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