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History of Changes for Study: NCT03108846
Escitalopram for Agitation in Alzheimer's Disease (S-CitAD)
Latest version (submitted May 6, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2017 None (earliest Version on record)
2 December 11, 2017 Recruitment Status, Contacts/Locations, Study Status, Eligibility, Outcome Measures, Arms and Interventions, Oversight and Study Identification
3 June 8, 2018 Contacts/Locations, Study Status and Eligibility
4 January 16, 2019 Contacts/Locations and Study Status
5 October 1, 2020 Contacts/Locations, Study Status, Eligibility and Study Description
6 May 6, 2021 Contacts/Locations, Study Status and Eligibility
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Study NCT03108846
Submitted Date:  April 6, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: S-CitAD
Brief Title: Escitalopram for Agitation in Alzheimer's Disease (S-CitAD)
Official Title: Escitalopram for Agitation in Alzheimer's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Not yet recruiting
Study Start: September 2017
Primary Completion: December 2020 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: April 6, 2017
First Submitted that
Met QC Criteria:
April 6, 2017
First Posted: April 11, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 6, 2017
Last Update Posted: April 11, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: JHSPH Center for Clinical Trials
Responsible Party: Principal Investigator
Investigator: Dave Shade
Official Title: Director, S-CitAD Coordinating Center
Affiliation: JHSPH Center for Clinical Trials
Collaborators: National Institute on Aging (NIA)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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 visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person 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 for the 24-week follow-up period.
Open or close this module Conditions
Conditions: Dementia
Keywords: Alzheimer's Disease
Agitation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 392 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Escitalopram
Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
Drug: Escitalopram
5-15 mg/day (target: 15mg/day if tolerated)
Other Names:
  • Lexapro
Placebo Comparator: Placebo
1-3 capsules each containing placebo only once per day in the morning
Drug: Placebo
Masked placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. mADCS-CGIC
[ Time Frame: after 12 weeks ]

Clinical Global Impression of Change
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 109 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Probable or known Alzheimer's Disease
  • Agitation for which treatment is suitable

Exclusion Criteria:

  • Major depressive episode
Open or close this module Contacts/Locations
Central Contact Person: Dave Shade, JD
Telephone: 4109558175
Email: dshade@jhmi.edu
Central Contact Backup: Stephan Ehrhardt, MD
Telephone: 4109558175
Email: sehrhar6@jhu.edu
Study Officials: Constantine Lyketsos, MD, MHS
Study Chair
Johns Hopkins University
Locations: United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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