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S-CitAD: Escitalopram for Agitation in Alzheimer's Disease

Sponsor
JHSPH Center for Clinical Trials (Other)
Overall Status
Recruiting
CT.gov ID
NCT03108846
Collaborator
National Institute on Aging (NIA) (NIH)
392
Enrollment
28
Locations
2
Arms
54.9
Anticipated Duration (Months)
14
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
392 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Over-encapsulation
Primary Purpose:
Treatment
Official Title:
Escitalopram for Agitation in Alzheimer's Disease
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
    Other Names:
  • non-applicable

    		•

    Outcome Measures

    Primary Outcome Measures

    1. modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) [after 12 weeks]

      Clinical Global Impression of Change

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 109 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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 Telephone (MMSET) score of 3-20 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'

    1. 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)

    2. 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

    3. Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all

    4. 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, anticonvulsants, 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:

    • antidepressants (other than trazodone, ≤ 100 mg per day at bedtime)

    • benzodiazepines (other than lorazepam), or

    • psychostimulants

    1. Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin

    2. Recent (< 14 days) use of medical marijuana

    3. Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes

    4. Significant communicative impairments that would affect participation in a clinical trial

    5. 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

    • if the QTcB is determined while the rhythm is paced, 50 ms is subtracted from the calculated value. The study cardiologist must confirm eligibility in this scenario.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Sun Health Research Institute Sun City Arizona United States 85351
    2 Biomedical Research Foundation Little Rock Arkansas United States 72205
    3 University of California Los Angeles/VA Greater Los Angeles Healthcare System Los Angeles California United States 90073
    4 University of Southern California Keck School of Medicine Memory and Aging Center Los Angeles California United States 90089
    5 Miami Jewish Health Systems Miami Florida United States 33137
    6 Maryland VA Health Care System Baltimore Maryland United States 21202
    7 Johns Hopkins University School of Medicine, Bayview Medical Center Baltimore Maryland United States 21224
    8 Clinical Insights Glen Burnie Maryland United States 20161
    9 Alzheimer Disease Center Quincy Massachusetts United States 02169
    10 Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada United States 89106
    11 Hackensack Meridian Health Hackensack New Jersey United States 07601
    12 Columbia University New York New York United States 10032
    13 University of Rochester Medical Center Rochester New York United States 14620
    14 Ohio State University Columbus Ohio United States 43221
    15 Abington Neurological Associates, Ltd Abington Pennsylvania United States 19001
    16 Alzheimer Disease Research Center; University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    17 Ralph H. Johnson VA Medical Center Charleston South Carolina United States 29401
    18 Roper St. Francis Healthcare Charleston South Carolina United States 29401
    19 Baylor AT&T Memory Center Dallas Texas United States 75231
    20 Eastern Virginia Medical School Norfolk Virginia United States 23510
    21 Northwest Clinical Research Center Bellevue Washington United States 98007
    22 University of Calgary and Foothills Medical Centre Calgary Alberta Canada
    23 Lawson Health Research Institute/Parkwood Institute London Ontario Canada N6C 0A7
    24 Neuropsychopharmacology Research Group, Sunnybrook Toronto Ontario Canada M4N 3M5
    25 Unity Health Toronto Ontario Canada M5B 1W8
    26 Centre for Addiction and Mental Health Toronto Ontario Canada M6J1H4
    27 Centre for Memory and Aging Toronto Ontario Canada
    28 Ontario Shores Whitby Ontario Canada L1N 5S9

    Sponsors and Collaborators

    • JHSPH Center for Clinical Trials
    • National Institute on Aging (NIA)

    Investigators

    • Study Chair: Constantine Lyketsos, MD, MHS, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dave Shade, Director, S-CitAD Coordinating Center, JHSPH Center for Clinical Trials
    ClinicalTrials.gov Identifier:
    NCT03108846
    Other Study ID Numbers:
    • S-CitAD
    • R01AG052510
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Dave Shade, Director, S-CitAD Coordinating Center, JHSPH Center for Clinical Trials
    Alzheimer's Disease
    Agitation
    Additional relevant MeSH terms:
    Alzheimer Disease
    Psychomotor Agitation
    Citalopram

    Study Results

    No Results Posted as of May 7, 2021