Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT03926520

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

Led by Brent Forester · Updated on 2026-04-28

50

Participants Needed

5

Research Sites

278 weeks

Total Duration

On this page

Sponsors

B

Brent Forester

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of dementia subtypes including Alzheimer's, Vascular, Frontotemporal, or Dementia with Lewy Bodies
  • Mini Mental Status Exam (MMSE) score of 15 or less
  • Severe agitation with a Cohen-Mansfield Agitation Inventory (CMAI) score of 5 or more on at least one item or 4 on two items indicating aggression or physical nonaggression with dangerous behaviors
  • At least one failed medication treatment for behavioral symptoms
  • Medically stable for safe ECT administration as verified by physical exam, lab tests, and brain imaging if needed
  • Ability to understand English
  • Authorized legal representative able and willing to provide informed consent
  • Age 40 years or older
Not Eligible

You will not qualify if you...

  • Current diagnosis of delirium
  • Vascular dementia due to stroke with abrupt onset and step-wise decline, confirmed by history, MRI within past 12 months, and physical/neurological exam
  • Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder, or Schizoaffective Disorder
  • Active substance use disorder within the past 6 months
  • ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) received within the past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Emory Healthcare

Atlanta, Georgia, United States, 30308

Actively Recruiting

2

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

3

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, United States, 49548

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

5

Northwell Health

Glen Oaks, New York, United States, 11004

Actively Recruiting

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Research Team

J

Jefferson Mattingly, BA

CONTACT

S

Sarah Howie, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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