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Escitalopram for Agitation in Alzheimer's Disease

Start: January 3, 2018
End: August 2022
Enrollment: 392

What Is This Study About?

Escitalopram (Lexapro) is a drug approved by the U.S. Food and Drug Administration for the treatment of depression and generalized anxiety disorder. This study will evaluate its safety and efficacy to treat agitation in Alzheimer's disease. Participants will be randomly assigned to take up to 15 mg per day of the study drug or a placebo (one to three 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 three weeks. If participants do not show a response, then they will be randomly assigned to the study drug or placebo.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: 109 Years

Must have:

  • 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 seven days

Must NOT have:

  • 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 seven days requiring a change in antipsychotic treatment
  • Abnormal corrected QT interval as determined on electrocardiogram (more than 450 ms for men and 470 ms for women)
  • Severely reduced renal function in past 30 days as identified by a Glomerular filtration rate clearance of less than 30 ml per minute or reduced liver function
  • Prohibited medications within seven 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 two weeks
  • Use of medical marijuana within two 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
 

Study Contact
Dave Shade, JD
410-955-8175
dshade@jhmi.edu
Stephan Ehrhardt, MD
410-955-8175
sehrhar6@jhu.edu

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
Banner Sun Health Research Institute
Sun City, AZ 85351
Not yet recruiting
Daneva MinerRose
623-832-5468
Daneva.MinerRose@bannerhealth.com
Arkansas
Biomedical Research Foundation
Little Rock, AR 72205
Recruiting
Prasad Padala
501-257-2537
ppadala@uams.edu
California
University of California Los Angeles/VA Greater Los Angeles Healthcare System
Los Angeles, CA 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, CA 90089
Recruiting
Mauricio Becerra, MD
323-442-7594
mjbecerr@usc.edu
Florida
Miami Jewish Health Systems
Miami, FL 33137
Recruiting
Alexander Gomez
305-751-8626
agomez@miamijewishhealth.org
Illinois
Northwestern University Feinberg School of Medicine
Chicago, IL 60611
Recruiting
Melody Fairchild
312-503-7071
m-fairchild@northwestern.edu
Maryland
Maryland VA Health Care System
Baltimore, MD 21202
Terminated
Johns Hopkins University School of Medicine, Bayview Medical Center
Baltimore, MD 21224
Recruiting
Nimra Jamil
410-550-9022
njamil2@jhmi.edu
Clinical Insights
Glen Burnie, MD 20161
Not yet recruiting
Norhan Ibrahim
410-768-2629
ibrahim@clinicalinsights.com
Massachusetts
Alzheimer Disease Center
Quincy, MA 02169
Recruiting
Mahak Kanjolia
617-302-6388
mahak@thealzcenter.org
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 89106
Recruiting
Monica Guerra
702-701-7893
GUERRAM@ccf.org
New York
Columbia University
New York, NY 10032
Recruiting
Judith Alvarez
646-774-8668
Judith.Alvarez@nyspi.columbia.edu
University of Rochester Medical Center
Rochester, NY 14620
Recruiting
Susan Salem-Spencer, RN, MSN
585-602-5203
Susan_Salem-Spencer@urmc.rochester.edu
Ohio
Ohio State University
Columbus, OH 43221
Recruiting
Brooke Eiginger
614-293-9023
Brooke.Eiginger@osumc.edu
Pennsylvania
Abington Neurological Associates, Ltd
Abington, PA 19001
Recruiting
Evan Cassar
215-957-9250
evancassar.ana@gmail.com
Alzheimer Disease Research Center; University of Pittsburgh
Pittsburgh, PA 15213
Recruiting
Patricia Henderson
412-692-2700
hendersonpl@upmc.edu
South Carolina
Roper St. Francis Healthcare
Charleston, SC 29401
Recruiting
Richard Freeman
843-724-2348
Richard.Freeman@rsfh.com
Texas
Baylor AT&T Memory Center
Dallas, TX 75231
Recruiting
Sarah Burris
214-818-0382
Sarah.Burris@BSWHealth.org
Virginia
Eastern Virginia Medical School
Norfolk, VA 23510
Recruiting
Patricia Sandov
757-446-5675
SandovPM@EVMS.EDU
Washington
Northwest Clinical Research Center
Bellevue, WA 98007
Terminated

Who Sponsors This Study?

Lead: JHSPH Center for Clinical Trials

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03108846