Escitalopram for Agitation in Alzheimer's Disease (S-CitAD)
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ClinicalTrials.gov Identifier: NCT03108846 |
Recruitment Status :
Recruiting
First Posted : April 11, 2017
Last Update Posted : May 7, 2021
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Sponsor:
JHSPH Center for Clinical Trials
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dave Shade, JHSPH Center for Clinical Trials
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 6, 2017 | ||||||||
First Posted Date ICMJE | April 11, 2017 | ||||||||
Last Update Posted Date | May 7, 2021 | ||||||||
Actual Study Start Date ICMJE | January 3, 2018 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) [ Time Frame: after 12 weeks ] Clinical Global Impression of Change
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Original Primary Outcome Measures ICMJE |
mADCS-CGIC [ Time Frame: after 12 weeks ] Clinical Global Impression of Change
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Escitalopram for Agitation in Alzheimer's Disease | ||||||||
Official Title ICMJE | Escitalopram for Agitation in Alzheimer's Disease | ||||||||
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia. | ||||||||
Detailed Description | This study is 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), will receive a structured psychosocial intervention. Participants not showing a response three weeks later will be randomized 1:1 to escitalopram (up to 15 mg/day) or a matching placebo. Participants will receive study drug for 12 weeks, with in-person and remote (phone/video) visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person and remote visits. Following the 12-week study treatment period, participants will be followed for another 12 weeks without receiving study drug. Participants who do show a response to the psychosocial intervention will not be randomized to study drug but will be followed remotely for the 24-week follow-up period. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Over-encapsulation Primary Purpose: Treatment
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Condition ICMJE | Dementia | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ehrhardt S, Porsteinsson AP, Munro CA, Rosenberg PB, Pollock BG, Devanand DP, Mintzer J, Rajji TK, Ismail Z, Schneider LS, Baksh SN, Drye LT, Avramopoulos D, Shade DM, Lyketsos CG; S-CitAD Research Group. 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
392 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 2022 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 109 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03108846 | ||||||||
Other Study ID Numbers ICMJE | S-CitAD R01AG052510 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Dave Shade, JHSPH Center for Clinical Trials | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | JHSPH Center for Clinical Trials | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | National Institute on Aging (NIA) | ||||||||
Investigators ICMJE |
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PRS Account | JHSPH Center for Clinical Trials | ||||||||
Verification Date | May 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |