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CitAD / S-CitAD |
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Citalopram / Escitalopram for Agitation in Alzheimer's Disease |
- Purposes and Goals
- Past and Present Studies
- Clinic Recruitment
- Participant Recruitment
- Publications
- Project Leadership
The management of agitation is a major priority in treating patients with AD. Non-pharmacologic options have limited effectiveness. Several pharmacologic options have been explored, but findings for anticonvulsants, antipsychotics, and cholinesterase inhibitors are disappointing or associated with questionable risk-benefit ratio, and better pharmacologic options are needed.
The goal of the CitAD Research Group is to investigate treatment options for patients with agitation and Alzheimer's disease.
S-CitAD (completed 2024)
S-CitAD was designed to examine the efficacy and safety of escitalopram as treatment for agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant agitation, and their caregiver(s), received a structured psychosocial intervention. Participants not showing a response three weeks later were randomized 1:1 to escitalopram (up to 15 mg/day) or a matching placebo. Participants received study drug for 12 weeks, with in-person visits at weeks 3, 6, and 12, and with telephone contacts between in-person visits. Following the 12-week study treatment period, participants were followed for another 12 weeks without receiving study drug. Participants who did show a response to the psychosocial intervention were not randomized to study drug but were followed for the 24-week follow-up period.
ClinicalTrials.Gov listing (ID: NCT03108846)
Access to S-CitAD Data
Deidentified S-CitAD data are available for health-related research. Access is contingent upon approval by an appropriate institutional ethics board (IRB, REB, etc.) and approval by the CitAD Steering Committee following review of a submitted CitAD Data Use Agreement form. Completed forms may be submitted by emailing citad@citadtrial.org
CitAD Data Use Agreement
CitAD, our first trial, was completed in 2013. This study was designed to examine the efficacy and safety of citalopram as treatment for clinically significant agitation in Alzheimer's dementia (AD) patients. It also investigated pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. Full results have been published (links below). We concluded that among patients with probable Alzheimer's disease and agitation receiving psychosocial intervention, the addition of citalopram compared with placebo significantly reduced agitation and caregiver distress, but cognitive and cardiac adverse effects of citalopram may limit its practical application at the 30 mg/d dose studied in this trial.
ClinicalTrials.Gov listing (ID: NCT00898807)
Primary publication in JAMA
Primary publication in PubMed Central
CitAD Trial Documents
Access to CitAD Data
Deidentified CitAD data are available for health-related research. Access is contingent upon approval by an appropriate institutional ethics board (IRB, REB, etc.) and approval by the CitAD Steering Committee following review of a submitted CitAD Data Use Agreement form. Completed forms may be submitted by emailing citad@citadtrial.org
CitAD Data Use Agreement
The CitAD Research Group is no longer seeking applications for new clinical centers to join our existing centers. S-CitAD was funded by the National Institute on Aging.
We would welcome interest from additional sites for future studies. For more information about the trial, and the application process, please visit our Application Page.
S-CitAD Application Page
Listing of S-CitAD Clinical Centers
We are not currently enrolling participants. For information about our clinic locations, please visit our ClinicalTrials.gov page by clicking the button marked "S-CitAD Clinical Centers"
S-CitAD Clinical Centers
Map of Enrolled Programs
The CitAD research group is led by Study Chair Constantine (Kostas) Lyketsos, MD, MHS, at the Johns Hopkins University School of Medicine.
The Vice-Chair is Anton Porsteinnson, MD, at the University of Rochester.
The study Coordinating Center is located in the Department of Epidemiology at the Johns Hopkins School of Public Health and is directed by Dave Shade, JD.