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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
Biomedical Research Foundation
Little Rock Arkansas 72205 Recruiting Prasad Padala
501-257-2537
ppadala@uams.edu
Irvine Clinical Research
Irvine California 92614 Not yet recruiting Tara Parnitvithikul
949-753-1663
tara@irvineclinical.com
University of California Los Angeles/VA Greater Los Angeles Healthcare System
Los Angeles California 90073 Recruiting Katie Bayard
310-478-3711
Katherine.Bayard@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 Not yet recruiting Melody Fairchild
312-503-7071
m-fairchild@northwestern.edu
Maryland VA Health Care System
Baltimore Maryland 21202 Not yet recruiting Joseph Schwartz
410-605-7358
Joseph.Schwartz@va.gov
Sheppard Pratt Health System
Baltimore Maryland 21204 Not yet recruiting Marylu Ortiz
410-938-3135
mortiz@sheppardpratt.org
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 Recruiting Norhan Ibrahim
410-768-2629
ibrahim@clinicalinsights.com
Alzheimer Disease Center
Quincy Massachusetts 02169 Recruiting Jayaprabha Mane
617-302-6388
drmane@thealzcenter.org
University of Michigan Program for Positive Aging
Ann Arbor Michigan 48109 Not yet recruiting Molly Turnwald
734-232-0393
turnwald@umich.edu
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 Laura Simon-Pearson
646-774-8671
laura.simonpearson@nyspi.columbia.edu
University of Rochester Medical Center
Rochester New York 14620 Recruiting Susan Salem-Spencer, RN, MSN
585-760-6562
Susan_Salem-Spencer@urmc.rochester.edu
Ohio State University
Columbus Ohio 43221 Recruiting Brooke Eiginger
614-293-9023
Brooke.Eiginger@osumc.edu
Alzheimer Disease Research Center; University of Pittsburgh
Pittsburgh Pennsylvania 15213 Recruiting Patricia Henderson
412-692-2703
hendersonpl@upmc.edu
Abington Neurological Associates, Ltd
Willow Grove Pennsylvania 19090 Recruiting Cheryl Pugh
215-957-9250
cherylpugh.ana@gmail.com
Roper St. Francis Healthcare
Charleston South Carolina 29401 Recruiting Arthur Williams
843-724-2053
Arthur.Williams@RoperSaintFrancis.com
Baylor AT&T Memory Center
Dallas Texas 75231 Recruiting Sarah Burris
214-818-2736
Sarah.Burris@BSWHealth.org
Northwest Clinical Research Center
Bellevue Washington 98007 Recruiting Leslie Gills
425-453-0404
lgills@nwcrc.net
University of Calgary and Foothills Medical Centre
Calgary Alberta Recruiting Ramnik Sekhon
(403) 210-7737
ramnik.sekhon@ucalgary.ca
Lawson Health Research Institute/Parkwood Institute
London Ontario N6C 0A7 Recruiting Betsy Schaefer
(519) 455-5110
Betsy.Schaefer@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 Kyle Lago, MD
416-535-8501
kyle.lago@camh.ca
Centre for Memory and Aging
Toronto Ontario Recruiting Mayrose Cornejo

mcornejo@memorycentre.ca

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