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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 : June 11, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dave Shade, JHSPH Center for Clinical Trials

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
Dementia Drug: Escitalopram Drug: Placebo 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 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 : Interventional  (Clinical Trial)
Estimated 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 : January 3, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : August 2022


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 Name: Lexapro

Placebo Comparator: Placebo
1-3 capsules each containing placebo only once per day in the morning
Drug: Placebo
Masked placebo
Other Name: non-applicable




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 109 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108846


Contacts
Contact: Dave Shade, JD 4109558175 dshade@jhmi.edu
Contact: Stephan Ehrhardt, MD 4109558175 sehrhar6@jhu.edu

Locations
United States, Arkansas
Biomedical Research Foundation Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Prasad Padala    501-257-2537    ppadala@uams.edu   
Contact: Chris Parkes    (501) 257-2504    christopher.parkes@va.gov   
Principal Investigator: Prasad Padala, MD         
United States, California
University of California Los Angeles/VA Greater Los Angeles Healthcare System Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Katie Bayard    310-478-3711 ext 44572    Katherine.Bayard@va.gov   
Contact: Alex Alas    (310)-478-3711    Alexander.Alas@va.gov   
Principal Investigator: David Sultzer, MD         
University of Southern California Keck School of Medicine Memory and Aging Center Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Mauricio Becerra, MD    323-442-7594    mjbecerr@usc.edu   
Principal Investigator: Lon S. Schneider, MD         
Sub-Investigator: Sonia Pawluczy, MD         
United States, Florida
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact: Alexander Gomez    305-751-8626 ext 64101    agomez@miamijewishhealth.org   
Principal Investigator: Marc Agronin, MD         
United States, Maryland
University of Maryland, School of Medicine, Clinical Neurobehavioral Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Donnette Deigh    667-214-2014    DDeigh@som.umaryland.edu   
Contact: Lawrence Adler, MD    667-214-2116    Ladler@som.umaryland.edu   
Principal Investigator: Lawrence Adler, MD         
Sheppard Pratt Health System Not yet recruiting
Baltimore, Maryland, United States, 21204
Contact: Marylu Ortiz    410-938-3135    mortiz@sheppardpratt.org   
Principal Investigator: Scott Tyler Aaronson, MD         
Johns Hopkins University School of Medicine, Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Nimra Jamil    410-550-9022    njamil2@jhmi.edu   
Principal Investigator: Paul Rosenberg, MD         
United States, Massachusetts
Alzheimer Disease Center Not yet recruiting
Quincy, Massachusetts, United States, 02169
Contact: Jayaprabha Mane    617-302-6388    drmane@thealzcenter.org   
Principal Investigator: Anil Nair, MD         
United States, Michigan
University of Michigan Program for Positive Aging Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Molly Turnwald    734-232-0393    turnwald@umich.edu   
Principal Investigator: Helen Kales, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Jessica D'Antonio    646-774-8674    dpd3@columbia.edu   
Principal Investigator: Davangere P. Devanand, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14620
Contact: Susan Salem-Spencer, RN, MSN    585-760-6562    Susan_Salem-Spencer@urmc.rochester.edu   
Principal Investigator: Anton Porsteinsson, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Brooke Eiginger    614-293-9023    Brooke.Eiginger@osumc.edu   
Principal Investigator: Douglas Scharre, MD         
United States, Pennsylvania
Alzheimer Disease Research Center; University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Patricia Henderson    412-692-2703    hendersonpl@upmc.edu   
Principal Investigator: Oscar Lopez, MD         
Abington Neurological Associates, Ltd Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: David Moore    215-957-9250    dlmoore416ana@gmail.com   
Contact: Gina Poland    (215) 957-9250 ext 3272    ginapoland.ana@gmail.com   
Principal Investigator: David Weisman, MD         
United States, South Carolina
Roper St. Francis Healthcare Not yet recruiting
Charleston, South Carolina, United States, 29401
Contact: Anthony Awkar    843-724-2216    anthony.awkar@rsfh.com   
Principal Investigator: Jacobo Mintzer, MD         
United States, Texas
Baylor AT&T Memory Center Recruiting
Dallas, Texas, United States, 75231
Contact: Brian Vilayvanh    214-818-0380    Brian.Vilayvanh@BSWHealth.org   
Principal Investigator: Cindy Marshall, MD         
Canada, Alberta
University of Calgary and Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Ramnik Sekhon    (403) 210-7737    ramnik.sekhon@ucalgary.ca   
Principal Investigator: Zahinoor Ismail, MD         
Canada, Ontario
Lawson Health Research Institute/Parkwood Institute Not yet recruiting
London, Ontario, Canada, N6C 0A7
Contact: Luli Pallaveshi    (519) 455-5110 ext 47326    Luli.Pallaveshi@sjhc.london.on.ca   
Principal Investigator: Amer Burhan, MD         
Neuropsychopharmacology Research Group, Sunnybrook Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Janelle Bradley    (416) 480-6100 ext 2241    jbradley@sri.utoronto.ca   
Principal Investigator: Nathan Herrmann, MD         
Centre for Addiction and Mental Health Not yet recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Kyle Lago, MD    416-535-8501 ext 32911    kyle.lago@camh.ca   
Principal Investigator: Bruce Pollock, MD         
Centre for Memory and Aging Not yet recruiting
Toronto, Ontario, Canada
Contact: Mayrose Cornejo       mcornejo@memorycentre.ca   
Principal Investigator: Giovanni Marotta, MD         
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institute on Aging (NIA)
Investigators
Study Chair: Constantine Lyketsos, MD, MHS Johns Hopkins University

Responsible Party: Dave Shade, Director, S-CitAD Coordinating Center, JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier: NCT03108846     History of Changes
Other Study ID Numbers: S-CitAD
R01AG052510 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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, JHSPH Center for Clinical Trials:
Alzheimer's Disease
Agitation

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics