Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial

Stephan Ehrhardt; Anton P Porsteinsson; Cynthia A Munro; Paul B Rosenberg; Bruce G Pollock; Davangere P Devanand; Jacobo Mintzer; Tarek K Rajji; Zahinoor Ismail; Lon S Schneider; Sheriza N Baksh; Lea T Drye; Dimitri Avramopoulos; David M Shade; Constantine G Lyketsos; S-CitAD Research Group

doi:10.1016/j.jalz.2019.06.4946

Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial

Alzheimers Dement. 2019 Nov;15(11):1427-1436. doi: 10.1016/j.jalz.2019.06.4946. Epub 2019 Oct 3.

Authors

Stephan Ehrhardt¹, Anton P Porsteinsson², Cynthia A Munro³, Paul B Rosenberg³, Bruce G Pollock⁴, Davangere P Devanand⁵, Jacobo Mintzer⁶, Tarek K Rajji⁴, Zahinoor Ismail⁷, Lon S Schneider⁸, Sheriza N Baksh⁹, Lea T Drye⁹, Dimitri Avramopoulos¹⁰, David M Shade⁹, Constantine G Lyketsos³; S-CitAD Research Group

Collaborators

S-CitAD Research Group:
Constantine G Lyketsos, Anton P Porsteinsson, Dimitri Avramopoulos, Cynthia Munro, Hochang Lee, Nicholas Bienko, Dave Shade, Stephan Ehrhardt, Jennifer Jones, Anne Shanklin Casper, Constantine Frangakis, Andy Lears, Sheriza Baksh, Jamie Perin, Laurie Ryan, Alvin D McKelvy, Paul Rosenberg, Milap Nowrangi, Sarah Lawrence, Meghan Schultz, Nimra Jamil, D P Devanand, Laura Simon-Pearson, Gregory Pelton Jacobo Mintzer, Olga Brawman-Mintzer, Arthur Williams, Anthony Awkar, Anton P Porsteinsson, Melanie Keltz, Nancy Kowalski, Kaitlyn Lane, Kim Martin, Susan Salem-Spencer, Asa Widman, Bruce G Pollock, Sanjeev Kumar, Lillian Lourenco, Benoit H Mulsant, Kyle Lago, Tarek K Rajji, Lon S Schneider, Maurcio Becerra, Karen Dagerman, Sonia Pawluczyk, Liberty Teodoro

Affiliations

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: sehrhar6@jhu.edu.
² Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
³ Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.
⁴ Campbell Family Research Institute and Division of Adult Neurodevelopment and Geriatric Psychiatry, CAMH, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
⁵ Division of Geriatric Psychiatry, New York State Psychiatric Institute and College of Physicians and Surgeons of Columbia University, New York, NY, USA.
⁶ Roper St. Francis Research and Innovation Center, Charleston, SC, USA; Medical University of South Carolina, College of Health Professionals and Ralph H Johnson VA Medical Center, Charleston, SC, USA.
⁷ Department of Psychiatry, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Clinical Neurosciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada.
⁸ Departments of Psychiatry and the Behavioral Sciences and Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA; Department of Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA.
⁹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁰ Department of Psychiatry and Behavioral Sciences, Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Abstract

Introduction: Alzheimer's disease (AD) is a disabling, common cause of dementia, and agitation is one of the most common and distressing symptoms for patients with AD. Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.

Methods: S-CitAD is a NIH-funded, investigator-initiated, randomized, multicenter clinical trial. Participants receive a structured psychosocial intervention (PSI) as standard of care. Participants without sufficient response to PSI are randomized to receive 15 mg escitalopram/day or a matching placebo in addition to PSI. Primary outcome is the Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC).

Discussion: S-CitAD will provide information about a practical, immediately available approach to treating agitation in patients with AD. S-CitAD may become a model of how to evaluate and predict treatment response in patients with AD and agitation as a neuropsychiatric symptom (ClinicalTrials.gov Identifier: NCT03108846).

Keywords: Agitation; Alzheimer dementia; Escitalopram; Neuropsychiatric symptoms; Psychosocial intervention; Randomized trial.

Publication types

Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Alzheimer Disease / complications*
Alzheimer Disease / psychology
Citalopram / therapeutic use*
Double-Blind Method
Female
Humans
Male
Psychiatric Status Rating Scales
Psychomotor Agitation / drug therapy*
Selective Serotonin Reuptake Inhibitors / therapeutic use*

Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial

Authors

Collaborators

Affiliations

Abstract

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MeSH terms

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Associated data

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