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

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

S-CitAD Research Group

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

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).

Original language	English (US)
Pages (from-to)	1427-1436
Number of pages	10
Journal	Alzheimer's and Dementia
Volume	15
Issue number	11
DOIs	https://doi.org/10.1016/j.jalz.2019.06.4946
State	Published - Nov 2019

Keywords

Agitation
Alzheimer dementia
Escitalopram
Neuropsychiatric symptoms
Psychosocial intervention
Randomized trial

ASJC Scopus subject areas

Epidemiology
Health Policy
Developmental Neuroscience
Clinical Neurology
Geriatrics and Gerontology
Cellular and Molecular Neuroscience
Psychiatry and Mental health

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10.1016/j.jalz.2019.06.4946

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@article{458c86d54e604d228ad14077648ab537,

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

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",

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

note = "Funding Information: Conflicts of interest: D.P.D. reports consulting for Eisai, Acadia, and Avanir. L.S.S. reports grants from NIA and the State of California, within 3 years and during the conduct of the study; grants from Eli Lilly, Merck, Novartis, Roche, Biogen, and UCSD and personal fees from AC Immune, Allergan, Avraham, Axovant, Boehringer Ingelheim, Cognition, Lilly Merck, Neurim, Roche, Takeda, Toyama, and vTv outside the submitted work. T.K.R. has received research support from Brain Canada, Brain and Behavior Research Foundation, BrightFocus Foundation, Canada Foundation for Innovation, Canada Research Chair, Canadian Institutes of Health Research, Centre for Aging and Brain Health Innovation, National Institutes of Health, Ontario Ministry of Health and Long-Term Care, Ontario Ministry of Research and Innovation, and the Weston Brain Institute. Z.I. has received funding from Brain Canada, Canadian Institutes of Health Research, and Canadian Consortium for Neurodegeneration and Aging. Consulting fees received from Allergan, Avanir, Janssen, Lilly, Lundbeck, Otsuka, Pfizer, and Sunovion. P.B.R. reports grants from NIA, Lilly, and Alzheimer's Association within 3 years and during the conduct of the study; consulting fees from GLG, Otsuka, Avanir, and Bionomics; travel support from Avanir and Otsuka. C.G.L. reports grants from NIMH, NIA, Associated Jewish Federation of Baltimore, Weinberg Foundation, Forest, GlaxoSmithKline, Eisai, Pfizer, Astra-Zeneca, Lilly, Ortho-McNeil, Bristol-Myers, Novartis, National Football League, Elan, Functional Neuromodulation, and BrightFocus Foundation. Consultant fees received from Astra-Zeneca, GlaxoSmithKline, Eisai, Novartis, Forest, Supernus, Adlyfe, Takeda, Wyeth, Lundbeck, Merz, Lilly, Pfizer, Genentech, Elan, NFL Players Association, NFL Benefits Office, Avanir, Zinfandel, BMS, AbbVie, Janssen, Orion, Otsuka, Servier, and Astellas. Honorarium or travel support from Pfizer, Forest, GlaxoSmithKline, and Health Monitor. J.M. reports consulting for ACADIA Pharmaceuticals and AVANIR Pharmaceuticals. A.P.P. reports personal fees from Acadia Pharmaceuticals, Functional Neuromodulation, Neurim Pharmaceuticals, Grifols, Eisai, Toyama, Biogen, Lundbeck, and Merck, grants from AstraZeneca, Avanir, Eisai, Biogen, Eli Lilly, Janssen, Genentech/Roche, Novartis, Merck, Transition Therapeutics, Toyama, NIA, NIMH, and DOD, and personal fees from Rockpointe, outside the submitted work. C.A.M., S.N.B., D.M.S., L.T.D., D.A., and S.E. report no conflicts of interest.S-CitAD wishes to acknowledge our patients and caregivers and their families as well as our recruitment centers across North America. We also acknowledge our funder, the National Institutes of Health/National Institute on Aging; R01AG052510. S-CitAD Research Group—Resource centers (responsibility: study administration)—Chair's Office, Johns Hopkins School of Medicine (Bayview), Baltimore, and University of Rochester, Rochester, New York: Constantine G. Lyketsos, MD, MHS, chair; Anton P. Porsteinsson, MD, co-chair; Dimitri Avramopoulos, MD, PhD, study geneticist; Cynthia Munro, PhD, study neuropsychologist; Hochang (Ben) Lee, MD, conflict of interest officer; and Nicholas Bienko, MS, lead coordinator. Coordinating Center, Johns Hopkins Bloomberg School of Public Health, Baltimore: Dave Shade, JD, director; Stephan Ehrhardt, MD, MPH, deputy director; Jennifer Jones, coordinator; Anne Shanklin Casper, MA, senior research program manager and coordinator; Constantine Frangakis, PhD, statistician; Andy Lears, data manager; Sheriza Baksh, PhD, MPH, analyst; and Jamie Perin, PhD, statistician. Project Office, National Institute on Aging, Bethesda: Laurie Ryan, PhD, Alvin D. McKelvy, PhD, project officers. Clinical centers (responsibility: data collection)—Johns Hopkins Bayview and Johns Hopkins School of Medicine, Baltimore: Paul Rosenberg, MD, director; Milap Nowrangi, MD, MBe, study physician; Sarah Lawrence, MS, research program manager; Meghan Schultz, RN, MSN, senior study nurse; and Nimra Jamil, lead coordinator. Columbia University Medical Center, Columbia: D.P. Devanand, MD, director; Laura Simon-Pearson, lead coordinator; and Gregory Pelton, MD. Roper St. Francis Research and Innovation Center: Jacobo Mintzer, MD, MBA, executive director; Olga Brawman-Mintzer, MD; Arthur Williams, study coordinator; and Anthony Awkar, study coordinator. University of Rochester School of Medicine and Dentistry, Rochester: Anton P. Porsteinsson, MD, director; Melanie Keltz, BS, RN; Nancy Kowalski, RN, CNSMS, RNC; Kaitlyn Lane, BA; Kim Martin, RN; Susan Salem-Spencer, RN, MSN, lead coordinator; and Asa Widman, BA. University of Toronto: Bruce G. Pollock, MD, PhD, FRCPC, director; Sanjeev Kumar, MD; Lillian Lourenco, MPH, lead coordinator; Benoit H. Mulsant, MD, MS; Kyle Lago, BA; and Tarek K. Rajji, MD. University of Southern California Keck School of Medicine: Lon S. Schneider, MD, director; Maurcio Becerra, lead coordinator; Karen Dagerman, MS; Sonia Pawluczyk, MD; and Liberty Teodoro, RN. Funding source: This study was funded by the National Institutes of Health/National Institute on Aging R01AG052510. The funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Funding Information: Funding source: This study was funded by the National Institutes of Health / National Institute on Aging R01AG052510 . The funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2019 the Alzheimer's Association",

year = "2019",

month = nov,

doi = "10.1016/j.jalz.2019.06.4946",

language = "English (US)",

volume = "15",

pages = "1427--1436",

journal = "Alzheimer's and Dementia",

issn = "1552-5260",

publisher = "Elsevier Inc.",

number = "11",

}

TY - JOUR

T1 - Escitalopram for agitation in Alzheimer's disease (S-CitAD)

T2 - Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial

AU - S-CitAD Research Group

AU - Ehrhardt, Stephan

AU - Porsteinsson, Anton P.

AU - Munro, Cynthia A.

AU - Rosenberg, Paul B.

AU - Pollock, Bruce G.

AU - Devanand, Davangere P.

AU - Mintzer, Jacobo

AU - Rajji, Tarek K.

AU - Ismail, Zahinoor

AU - Schneider, Lon S.

AU - Baksh, Sheriza N.

AU - Drye, Lea A

AU - Avramopoulos, Dimitri

AU - Shade, David M.

AU - Lyketsos, Constantine G.

AU - Munro, Cynthia

AU - Lee, Hochang

AU - Bienko, Nicholas

AU - Shade, Dave

AU - Jones, Jennifer

AU - Casper, Anne Shanklin

AU - Frangakis, Constantine

AU - Lears, Andy

AU - Baksh, Sheriza

AU - Perin, Jamie

AU - Ryan, Laurie

AU - McKelvy, Alvin D.

AU - Rosenberg, Paul

AU - Nowrangi, Milap

AU - Lawrence, Sarah

AU - Schultz, Meghan

AU - Jamil, Nimra

AU - Devanand, D. P.

AU - Simon-Pearson, Laura

AU - Pelton Jacobo Mintzer, Gregory

AU - Brawman-Mintzer, Olga

AU - Williams, Arthur

AU - Awkar, Anthony

AU - Keltz, Melanie

AU - Kowalski, Nancy

AU - Lane, Kaitlyn

AU - Martin, Kim

AU - Salem-Spencer, Susan

AU - Widman, Asa

AU - Kumar, Sanjeev

AU - Lourenco, Lillian

AU - Mulsant, Benoit H.

AU - Lago, Kyle

AU - Becerra, Maurcio

AU - Dagerman, Karen

N1 - Funding Information: Conflicts of interest: D.P.D. reports consulting for Eisai, Acadia, and Avanir. L.S.S. reports grants from NIA and the State of California, within 3 years and during the conduct of the study; grants from Eli Lilly, Merck, Novartis, Roche, Biogen, and UCSD and personal fees from AC Immune, Allergan, Avraham, Axovant, Boehringer Ingelheim, Cognition, Lilly Merck, Neurim, Roche, Takeda, Toyama, and vTv outside the submitted work. T.K.R. has received research support from Brain Canada, Brain and Behavior Research Foundation, BrightFocus Foundation, Canada Foundation for Innovation, Canada Research Chair, Canadian Institutes of Health Research, Centre for Aging and Brain Health Innovation, National Institutes of Health, Ontario Ministry of Health and Long-Term Care, Ontario Ministry of Research and Innovation, and the Weston Brain Institute. Z.I. has received funding from Brain Canada, Canadian Institutes of Health Research, and Canadian Consortium for Neurodegeneration and Aging. Consulting fees received from Allergan, Avanir, Janssen, Lilly, Lundbeck, Otsuka, Pfizer, and Sunovion. P.B.R. reports grants from NIA, Lilly, and Alzheimer's Association within 3 years and during the conduct of the study; consulting fees from GLG, Otsuka, Avanir, and Bionomics; travel support from Avanir and Otsuka. C.G.L. reports grants from NIMH, NIA, Associated Jewish Federation of Baltimore, Weinberg Foundation, Forest, GlaxoSmithKline, Eisai, Pfizer, Astra-Zeneca, Lilly, Ortho-McNeil, Bristol-Myers, Novartis, National Football League, Elan, Functional Neuromodulation, and BrightFocus Foundation. Consultant fees received from Astra-Zeneca, GlaxoSmithKline, Eisai, Novartis, Forest, Supernus, Adlyfe, Takeda, Wyeth, Lundbeck, Merz, Lilly, Pfizer, Genentech, Elan, NFL Players Association, NFL Benefits Office, Avanir, Zinfandel, BMS, AbbVie, Janssen, Orion, Otsuka, Servier, and Astellas. Honorarium or travel support from Pfizer, Forest, GlaxoSmithKline, and Health Monitor. J.M. reports consulting for ACADIA Pharmaceuticals and AVANIR Pharmaceuticals. A.P.P. reports personal fees from Acadia Pharmaceuticals, Functional Neuromodulation, Neurim Pharmaceuticals, Grifols, Eisai, Toyama, Biogen, Lundbeck, and Merck, grants from AstraZeneca, Avanir, Eisai, Biogen, Eli Lilly, Janssen, Genentech/Roche, Novartis, Merck, Transition Therapeutics, Toyama, NIA, NIMH, and DOD, and personal fees from Rockpointe, outside the submitted work. C.A.M., S.N.B., D.M.S., L.T.D., D.A., and S.E. report no conflicts of interest.S-CitAD wishes to acknowledge our patients and caregivers and their families as well as our recruitment centers across North America. We also acknowledge our funder, the National Institutes of Health/National Institute on Aging; R01AG052510. S-CitAD Research Group—Resource centers (responsibility: study administration)—Chair's Office, Johns Hopkins School of Medicine (Bayview), Baltimore, and University of Rochester, Rochester, New York: Constantine G. Lyketsos, MD, MHS, chair; Anton P. Porsteinsson, MD, co-chair; Dimitri Avramopoulos, MD, PhD, study geneticist; Cynthia Munro, PhD, study neuropsychologist; Hochang (Ben) Lee, MD, conflict of interest officer; and Nicholas Bienko, MS, lead coordinator. Coordinating Center, Johns Hopkins Bloomberg School of Public Health, Baltimore: Dave Shade, JD, director; Stephan Ehrhardt, MD, MPH, deputy director; Jennifer Jones, coordinator; Anne Shanklin Casper, MA, senior research program manager and coordinator; Constantine Frangakis, PhD, statistician; Andy Lears, data manager; Sheriza Baksh, PhD, MPH, analyst; and Jamie Perin, PhD, statistician. Project Office, National Institute on Aging, Bethesda: Laurie Ryan, PhD, Alvin D. McKelvy, PhD, project officers. Clinical centers (responsibility: data collection)—Johns Hopkins Bayview and Johns Hopkins School of Medicine, Baltimore: Paul Rosenberg, MD, director; Milap Nowrangi, MD, MBe, study physician; Sarah Lawrence, MS, research program manager; Meghan Schultz, RN, MSN, senior study nurse; and Nimra Jamil, lead coordinator. Columbia University Medical Center, Columbia: D.P. Devanand, MD, director; Laura Simon-Pearson, lead coordinator; and Gregory Pelton, MD. Roper St. Francis Research and Innovation Center: Jacobo Mintzer, MD, MBA, executive director; Olga Brawman-Mintzer, MD; Arthur Williams, study coordinator; and Anthony Awkar, study coordinator. University of Rochester School of Medicine and Dentistry, Rochester: Anton P. Porsteinsson, MD, director; Melanie Keltz, BS, RN; Nancy Kowalski, RN, CNSMS, RNC; Kaitlyn Lane, BA; Kim Martin, RN; Susan Salem-Spencer, RN, MSN, lead coordinator; and Asa Widman, BA. University of Toronto: Bruce G. Pollock, MD, PhD, FRCPC, director; Sanjeev Kumar, MD; Lillian Lourenco, MPH, lead coordinator; Benoit H. Mulsant, MD, MS; Kyle Lago, BA; and Tarek K. Rajji, MD. University of Southern California Keck School of Medicine: Lon S. Schneider, MD, director; Maurcio Becerra, lead coordinator; Karen Dagerman, MS; Sonia Pawluczyk, MD; and Liberty Teodoro, RN. Funding source: This study was funded by the National Institutes of Health/National Institute on Aging R01AG052510. The funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Funding Information: Funding source: This study was funded by the National Institutes of Health / National Institute on Aging R01AG052510 . The funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Publisher Copyright: © 2019 the Alzheimer's Association

PY - 2019/11

Y1 - 2019/11

N2 - 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).

AB - 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).

KW - Agitation

KW - Alzheimer dementia

KW - Escitalopram

KW - Neuropsychiatric symptoms

KW - Psychosocial intervention

KW - Randomized trial

UR - http://www.scopus.com/inward/record.url?scp=85072777249&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85072777249&partnerID=8YFLogxK

U2 - 10.1016/j.jalz.2019.06.4946

DO - 10.1016/j.jalz.2019.06.4946

M3 - Article

C2 - 31587995

AN - SCOPUS:85072777249

SN - 1552-5260

VL - 15

SP - 1427

EP - 1436

JO - Alzheimer's and Dementia

JF - Alzheimer's and Dementia

IS - 11

ER -

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

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