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Trial record 1 of 1 for:    NCT 03108846
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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 : March 8, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dave Shade, JHSPH Center for Clinical Trials

Study Description
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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 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
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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 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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'
  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, 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
  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

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

Locations
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Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institute on Aging (NIA)
Investigators
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Study Chair: Constantine Lyketsos, MD, MHS Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alzheimer Disease
Psychomotor Agitation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
 Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Escitalopram
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs