Skip to main content

Escitalopram for Agitation in Alzheimer's Disease

Recruiting

This study will evaluate the safety and efficacy of escitalopram (Lexapro) to treat agitation in Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 109 Years All No
January 3, 2018
August 2022
392

  • Alzheimer's dementia diagnosis
  • Mini-Mental State Examination score of 5 to 28
  • Meets criteria for agitation in cognitive disorders per the International Psychogeriatric Association
  • Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory
  • Availability of a caregiver who spends at least several hours per week with the participant, supervises his or her care, and is willing to accompany the participant to study visits and participate in the study
  • Use of antipsychotics for agitation or psychosis must be stable for at least 7 days

  • Major depression in the past 90 days
  • Brain disease other than Alzheimer's that explains the dementia, such as 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 facility 
  • Contraindication to escitalopram, such as use of monoamine oxidase inhibitors in past 30 days or sensitivity to escitalopram or citalopram (Celexa) or any inactive ingredients
  • Prior failed treatment with citalopram or escitalopram for agitation
  • Indication for psychiatric hospitalization or acute suicidality
  • Changes in antipsychotics, including brexpiprazole or psychosis (delusions or hallucinations) within 7 days requiring a change in antipsychotic treatment
  • Abnormal corrected QT interval as determined on electrocardiogram (more than 450 milliseconds for men and 470 milliseconds for women)
  • Severely reduced renal function in past 30 days as identified by a Glomerular filtration rate clearance of less than 30 milliliters per minute or reduced liver function
  • Prohibited medications within 7 days: anticonvulsants (other than dilantin for seizures), antidepressants (other than 50 mg or less of trazodone per day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants
  • Changes in dextromethorphan/quinidine, prazosin, and pimavanserin within 2 weeks
  • Use of medical marijuana within 2 weeks
  • Current participation in a clinical trial or study that may add a significant burden or affect study outcomes
  • Significant communicative impairments that would affect participation
  • Any condition that makes it medically inappropriate or risky to enroll in the trial

Escitalopram is a drug approved by the U.S. Food and Drug Administration for the treatment of depression and generalized anxiety disorder. In this study researchers are investigating whether the drug could help treat agitation in people with Alzheimer's disease. Participants will be randomly assigned to take up to 15 milligrams per day of the study drug or a placebo (1 to 3 capsules per day) for 12 weeks. Before being assigned to the drug intervention, participants with clinically significant agitation and their caregiver(s) will receive a structured psychosocial intervention for 3 weeks. If participants do not show a response, then they will be randomly assigned to the study drug or placebo.

Name City State Zip Status Primary Contact
Banner Sun Health Research Institute
Sun City Arizona 85351 Not yet recruiting Daneva MinerRose
623-832-5468
Daneva.MinerRose@bannerhealth.com
Biomedical Research Foundation
Little Rock Arkansas 72205 Recruiting Prasad Padala
501-257-2537
ppadala@uams.edu
University of California Los Angeles/VA Greater Los Angeles Healthcare System
Los Angeles California 90073 Recruiting Alex Alas
310-478-3711
Alexander.Alas@va.gov
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles California 90089 Recruiting Mauricio Becerra, MD
323-442-7594
mjbecerr@usc.edu
Miami Jewish Health Systems
Miami Florida 33137 Recruiting Alexander Gomez
305-751-8626
agomez@miamijewishhealth.org
Northwestern University Feinberg School of Medicine
Chicago Illinois 60611 Recruiting Melody Fairchild
312-503-7071
m-fairchild@northwestern.edu
Maryland VA Health Care System
Baltimore Maryland 21202 Terminated

Johns Hopkins University School of Medicine, Bayview Medical Center
Baltimore Maryland 21224 Recruiting Nimra Jamil
410-550-9022
njamil2@jhmi.edu
Clinical Insights
Glen Burnie Maryland 20161 Not yet recruiting Norhan Ibrahim
410-768-2629
ibrahim@clinicalinsights.com
Alzheimer Disease Center
Quincy Massachusetts 02169 Recruiting Mahak Kanjolia
617-302-6388
mahak@thealzcenter.org
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106 Recruiting Monica Guerra
702-701-7893
GUERRAM@ccf.org
Columbia University
New York New York 10032 Recruiting Judith Alvarez
646-774-8668
Judith.Alvarez@nyspi.columbia.edu
University of Rochester Medical Center
Rochester New York 14620 Recruiting Susan Salem-Spencer, RN, MSN
585-602-5203
Susan_Salem-Spencer@urmc.rochester.edu
Ohio State University
Columbus Ohio 43221 Recruiting Brooke Eiginger
614-293-9023
Brooke.Eiginger@osumc.edu
Abington Neurological Associates, Ltd
Abington Pennsylvania 19001 Recruiting Evan Cassar
215-957-9250
evancassar.ana@gmail.com
Alzheimer Disease Research Center; University of Pittsburgh
Pittsburgh Pennsylvania 15213 Recruiting Patricia Henderson
412-692-2700
hendersonpl@upmc.edu
Roper St. Francis Healthcare
Charleston South Carolina 29401 Recruiting Richard Freeman
843-724-2348
Richard.Freeman@rsfh.com
Baylor AT&T Memory Center
Dallas Texas 75231 Recruiting Sarah Burris
214-818-0382
Sarah.Burris@BSWHealth.org
Eastern Virginia Medical School
Norfolk Virginia 23510 Recruiting Patricia Sandov
757-446-5675
SandovPM@EVMS.EDU
Northwest Clinical Research Center
Bellevue Washington 98007 Terminated

University of Calgary and Foothills Medical Centre
Calgary Alberta Recruiting Sharanjit Kaur
(403) 210-7737
sharanjit.kaur@ucalgary.ca
Lawson Health Research Institute/Parkwood Institute
London Ontario N6C 0A7 Recruiting Emily Ionson
519-685-8500
emily.ionson@lhsc.on.ca
Neuropsychopharmacology Research Group, Sunnybrook
Toronto Ontario M4N 3M5 Recruiting Abby Li
(416) 480-6100
Abby.Li@sunnybrook.ca
Centre for Addiction and Mental Health
Toronto Ontario M6J1H4 Recruiting Rhea Harduwar, MD
416-535-8501
Rhea.Harduwar@camh.ca
Centre for Memory and Aging
Toronto Ontario Terminated

JHSPH Center for Clinical Trials

  • National Institute on Aging (NIA)

Name Role Affiliation
Constantine Lyketsos, MD, MHS Study Chair Johns Hopkins University

Name Phone Email
Dave Shade, JD 410-955-8175 dshade@jhmi.edu
Stephan Ehrhardt, MD 410-955-8175 sehrhar6@jhu.edu

NCT03108846

Escitalopram for Agitation in Alzheimer's Disease