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

• Published in: Alzheimer's & dementia Vol. 15; no. 11; pp. 1427 - 1436
• Main Authors: Ehrhardt, Stephan, Porsteinsson, Anton P., Munro, Cynthia A., Rosenberg, Paul B., Pollock, Bruce G., Devanand, Davangere P., Mintzer, Jacobo, Rajji, Tarek K., Ismail, Zahinoor, Schneider, Lon S., Baksh, Sheriza N., Drye, Lea T., Avramopoulos, Dimitri, Shade, David M., Lyketsos, Constantine G., Munro, Cynthia, Lee, Hochang, Bienko, Nicholas, Shade, Dave, Jones, Jennifer, Casper, Anne Shanklin, Frangakis, Constantine, Lears, Andy, Baksh, Sheriza, Perin, Jamie, Ryan, Laurie, McKelvy, Alvin D., Rosenberg, Paul, Nowrangi, Milap, Lawrence, Sarah, Schultz, Meghan, Jamil, Nimra, Devanand, D.P., Simon-Pearson, Laura, Pelton Jacobo Mintzer, Gregory, Brawman-Mintzer, Olga, Williams, Arthur, Awkar, Anthony, Keltz, Melanie, Kowalski, Nancy, Lane, Kaitlyn, Martin, Kim, Salem-Spencer, Susan, Widman, Asa, Kumar, Sanjeev, Lourenco, Lillian, Mulsant, Benoit H., Lago, Kyle, Becerra, Maurcio, Dagerman, Karen, Pawluczyk, Sonia, Teodoro, Liberty
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-11-2019
• Subjects: Agitation; Alzheimer dementia; Escitalopram; Neuropsychiatric symptoms; Psychosocial intervention; Randomized trial; Agitation; Psychosocial intervention; Randomized trial; Escitalopram; Alzheimer dementia; Neuropsychiatric symptoms
• ISSN: 1552-5260; 1552-5279
• DOI: 10.1016/j.jalz.2019.06.4946

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.
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).
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).