Summary

for people ages 18-109 (full criteria)
at UCLA
study started
estimated completion
David Sultzer (ucla)

Description

Summary

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

Details

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.

Keywords

Dementia Alzheimer's Disease Agitation Alzheimer Disease Psychomotor Agitation Citalopram Dexetimide Escitalopram

Eligibility

You can join if…

Open to people ages 18-109

  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'
  • 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)
  • 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
  • Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
  • A medication for agitation is appropriate, in the opinion of the study physician

You CAN'T join if...

  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:
  11. anticonvulsants (other than Dilantin for seizures)
  12. antidepressants (other than trazodone, ≤ 50 mg per day at bedtime)
  13. benzodiazepines (other than lorazepam), or
  14. psychostimulants
  15. . Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
  16. . Recent (< 14 days) use of medical marijuana
  17. . Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
  18. . Significant communicative impairments that would affect participation in a clinical trial
  19. . 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

Locations

  • University of California Los Angeles/VA Greater Los Angeles Healthcare System accepting new patients
    Los Angeles California 90073 United States
  • Irvine Clinical Research not yet accepting patients
    Irvine California 92614 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
JHSPH Center for Clinical Trials
ID
NCT03108846
Phase
Phase 3
Study Type
Interventional
Last Updated