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

NCT03926520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-28

No results posted yet for this 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.

Conditions

  • Alzheimer Dementia
  • Agitation,Psychomotor

Interventions

DEVICE

Electroconvulsive Therapy (ECT)

Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Pine Rest Christian Mental Health Services

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • The Zucker Hillside Hospital

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Brent Forester

    lead OTHER

Principal Investigators

  • Brent P Forester, MD, MSc · Mclean Hospital

  • George Petrides, MD · Northwell Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926520 on ClinicalTrials.gov