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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 : January 17, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dave Shade, JHSPH Center for Clinical Trials

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date January 17, 2019
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
 (submitted: December 11, 2017)
modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) [ Time Frame: after 12 weeks ]
Clinical Global Impression of Change
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
mADCS-CGIC [ Time Frame: after 12 weeks ]
Clinical Global Impression of Change
Change History Complete list of historical versions of study NCT03108846 on ClinicalTrials.gov Archive Site
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 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.
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
Condition  ICMJE Dementia
Intervention  ICMJE
  • Drug: Escitalopram
    5-15 mg/day (target: 15mg/day if tolerated)
    Other Name: Lexapro
  • Drug: Placebo
    Masked placebo
    Other Name: non-applicable
Study Arms  ICMJE
  • Experimental: Escitalopram
    Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    1-3 capsules each containing placebo only once per day in the morning
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
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

  1. Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
  2. Mini-Mental State Examination (MMSE) score of 5-28 inclusive
  3. Meets the International Psychogeriatric Association (IPA) provisional criteria for agitation in cognitive disorders
  4. Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory (NPI) for which either:

    • The frequency is 'Very frequently,' or
    • The frequency is 'Frequently' AND the severity is 'Moderate' or 'Marked'
  5. Provision of informed consent for participation in the study by both caregiver and participant (or, if participant is unable to provide informed consent, with surrogate consent and participant assent)
  6. Availability of a caregiver who spends at least several hours per week with the participant, supervises his/her care, is willing to accompany the participant to study visits, and is willing to participate in the study
  7. Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
  8. A medication for agitation is appropriate, in the opinion of the study physician

Exclusion criteria

  1. Has major depression, as indicated by major depressive episode (MDE) in the past 90 days (meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria)
  2. Presence of another brain disease that fully explains the dementia, (e.g., extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
  3. Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility
  4. Contraindication to treatment with escitalopram as determined by a study physician, such as recent (30 days) use of monoamine oxidase inhibitors (MAOIs) or potential participant is hypersensitive to escitalopram or citalopram or any inactive ingredients
  5. Prior failed treatment attempt with citalopram or escitalopram for agitation after adequate trial, at minimally accepted dose
  6. Indication for psychiatric hospitalization or acute suicidality, in the opinion of the study physician
  7. Recent (< 7 days) changes in antipsychotics (including brexpiprazole), or psychosis (delusions or hallucinations) requiring a new or change in antipsychotic treatment (in the opinion of the study physician)
  8. Abnormal corrected QT interval using Bazett's formula (QTcB) as determined on enrollment ECG (defined as > 450 ms for men and > 470 ms for women)
  9. Recent (30 days) presence of severely reduced renal function (as identified by a Glomerular filtration rate (GFR) clearance < 30 mL/min) or reduced hepatic function
  10. Current treatment (within 7 days) with any of the following:

    • anticonvulsants (other than Dilantin for seizures)
    • antidepressants (other than trazodone, ≤ 50 mg per day at bedtime)
    • benzodiazepines (other than lorazepam), or
    • psychostimulants
  11. Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
  12. Recent (< 14 days) use of medical marijuana
  13. Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
  14. Significant communicative impairments that would affect participation in a clinical trial
  15. Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the potential participant to enroll in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 109 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dave Shade, JD 4109558175 dshade@jhmi.edu
Contact: Stephan Ehrhardt, MD 4109558175 sehrhar6@jhu.edu
Listed Location Countries  ICMJE United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03108846
Other Study ID Numbers  ICMJE S-CitAD
R01AG052510 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dave Shade, JHSPH Center for Clinical Trials
Study Sponsor  ICMJE JHSPH Center for Clinical Trials
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Study Chair: Constantine Lyketsos, MD, MHS Johns Hopkins University
PRS Account JHSPH Center for Clinical Trials
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP