Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)

Last updated: May 30, 2024
Sponsor: Brent Forester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Williams Syndrome

Manic Disorders

Treatment

Electroconvulsive Therapy (ECT)

Clinical Study ID

NCT03926520
2020P002276
  • Ages > 40
  • All Genders

Study Summary

This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Diagnosis of Dementia, of the following subtypes,

  2. Alzheimer's dementia, according to NIA-AA Criteria for dementia

  3. Vascular dementia based on: i. History consistent with insidious onset of illness and gradual clinical declineii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical andneurological examination do not indicate current or prior stroke c. Frontotemporaldementia d. Dementia with Lewy Bodies

  4. Mini Mental Status Exam (MMSE) less than or equal to 15

  5. Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or moreon at least one item or score of 4 on two items of aggression or physicalnonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting,scratching, spitting, hurting self or other, tearing things or destroying property,making physical sexual advances, trying to get to a different place, or intentionalfalling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggressionincluding screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).

  6. At least one failed pharmacological intervention to manage behavioral symptoms

  7. Medically stable for safe administration of ECT verified by standard physicalexamination, urinalysis and serum chemistries and brain imaging when clinicallyindicated

  8. Comprehension of English language

  9. Authorized legal representative able and willing to give informed consent

  10. Age 40 and above

Exclusion

Exclusion Criteria:

  1. Current diagnosis of co-morbid delirium, measured by the Confusion AssessmentMeasure (CAM) and by clinical diagnosis

  2. Diagnosis of vascular dementia due to stroke, based on:

  • History consistent with abrupt onset and step-wise progression of cognitive andfunctional decline

  • MRI scan within the past 12 months demonstrating evidence of hemorrhagic andembolic stroke

  • Physical and neurologic examination consistent with current or prior stroke

  1. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or SchizoaffectiveDisorder

  2. Active substance use disorder within past 6 months

  3. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nervestimulation) within the past 3 months

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Electroconvulsive Therapy (ECT)
Phase:
Study Start date:
January 28, 2021
Estimated Completion Date:
May 31, 2025

Study Description

This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.

Connect with a study center

  • Emory Healthcare

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • McLean Hospital

    Belmont, Massachusetts 02478
    United States

    Active - Recruiting

  • Pine Rest Christian Mental Health Services

    Grand Rapids, Michigan 49548
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Northwell Health

    Glen Oaks, New York 11004
    United States

    Active - Recruiting

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