Escitalopram for Agitation in Alzheimer's Disease

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?

Must have:

• Alzheimer's dementia diagnosis
• Mini-Mental State Examination Telephone score of 3-20
• 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, anticonvulsants, 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:  antidepressants (other than 100 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Arizona
Banner Sun Health Research Institute Sun City, AZ 85351 Recruiting Kelly Clark 623-832-6527 kelly.Clark2@bannerhealth.com
Arkansas
Biomedical Research Foundation Little Rock, AR 72205 Recruiting Prasad Padala 501-257-2537 ppadala@uams.edu
University of Arkansas for Medical Sciences Little Rock, AR 72205 Recruiting Pat Savary 501-526-5701 pesavary@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
Stanford Center for Precision Mental Health and Wellness Stanford, CA 94305 Recruiting Isabelle Cotto 650-723-2795 ijoly@stanford.edu
District of Columbia
Washington DC VA Medical Center Washington, DC 20422 Recruiting Claudia Gunawan 559-824-5121 claudia.gunawan@va.gov
Florida
Miami Jewish Health Systems Miami, FL 33137 Recruiting Alexander Gomez 305-751-8626 agomez@miamijewishhealth.org
Kansas
Kansas School of Medicine-Wichita Center for Clinical Research Wichita, KS 67214 Recruiting Allie Archer aarcher2@kumc.edu
Johns Hopkins University School of Medicine, Bayview Medical Center Baltimore, MD 21224 Recruiting Mersania Jn Pierre 410-550-4969 mjnpier1@jhmi.edu
New Jersey
Hackensack Meridian Health Hackensack, NJ 07601 Not yet recruiting Domenica Vapore 551-996-8100 domenica.vapore@hmhn.org
New York
NYU Langone Health New York, NY 10016 Not yet recruiting Brittany Marti 212-263-5708 brittany.marti@nyulangone.org
Columbia University New York, NY 10032 Recruiting Jamie Graff 646-774-8638 jamie.graff@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
Stony Brook University Hospital Stony Brook, NY 11794 Not yet recruiting Nikhil Palekar, MD 631-632-2428 nikhil.palekar@stonybrookmedicine.edu
Ohio
University Hospitals Cleveland Medical Center/ Case Western Cleveland, OH 44122 Recruiting Srishti Ahuja srishti.ahuja@uhhospitals.org
Ohio State University Columbus, OH 43221 Recruiting Emily Shalosky 614-293-5183 emily.shalosky@osumc.edu
Pennsylvania
Abington Neurological Associates, Ltd Abington, PA 19001 Recruiting Angela Robinson 215-957-9250 angiescott.ana@gmail.com
Alzheimer Disease Research Center; University of Pittsburgh Pittsburgh, PA 15213 Recruiting Patricia Henderson 412-692-2700 hendersonpl@upmc.edu
Texas
Baylor AT&T Memory Center Dallas, TX 75231 Recruiting Nazleen Sherali 214-818-0380 Nazleen.Sherali@BSWHealth.org
UT Health San Antonio San Antonio, TX 78229 Recruiting Marlina Novoa 210-450-8143 novoa@uthscsa.edu
Virginia
University of Virginia Adult Neurology Charlottesville, VA 22903 Recruiting Colleen Webber cmn6x@virginia.edu
Eastern Virginia Medical School Norfolk, VA 23510 Recruiting Kaitlin Romm 757-446-7406 RommKE@EVMS.EDU

Who Sponsors This Study?

Lead: JHSPH Center for Clinical Trials

Collaborator Sponsor

• National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03108846