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

NCT03926520 | Recruiting DMC FDA Device

• 1 other identifier: 2020P002276
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

ECT; Agitation; Alzheimer's; Dementia

Outcome Measures

Primary Outcomes (1)

• CMAI total score

  The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.

  The CMAI will be collected through study completion, about 13 months

Secondary Outcomes (3)

• Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)

  The ADCS-CGIC will be collected for one month

• Neuropsychiatric Inventory, Clinician Version (NPI-C)

  The NPI-C will be collected for one month

• Pittsburgh Agitation Scale (PAS)

  The PAS will be collected for one month

Study Arms (1)

ECT+UC group

EXPERIMENTAL

ECT with Usual Care

Device: Electroconvulsive Therapy (ECT)

Interventions

Electroconvulsive Therapy (ECT) DEVICE

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.

ECT+UC group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Dementia, of the following subtypes,
• Alzheimer's dementia, according to NIA-AA Criteria for dementia
• Vascular dementia based on:
• i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies
• Mini Mental Status Exam (MMSE) less than or equal to 15
• Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression 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 intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).
• At least one failed pharmacological intervention to manage behavioral symptoms
• Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated
• Comprehension of English language
• Authorized legal representative able and willing to give informed consent
• Age 40 and above

You may not qualify if:

• Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
• Diagnosis of vascular dementia due to stroke, based on:
• History consistent with abrupt onset and step-wise progression of cognitive and functional decline
• MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
• Physical and neurologic examination consistent with current or prior stroke
• Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
• Active substance use disorder within past 6 months
• Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months

Sponsors & Collaborators

• Brent Forester: lead
• Mayo Clinic: collaborator
• Pine Rest Christian Mental Health Services: collaborator
• Emory University: collaborator
• The Zucker Hillside Hospital: collaborator
• Medical University of South Carolina: collaborator

Study Sites (5)

Emory Healthcare

Atlanta, Georgia, 30308, United States

RECRUITING

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, 49548, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Northwell Health

Glen Oaks, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Brent P Forester, MD, MSc

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• George Petrides, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jefferson Mattingly, BA

CONTACT

617-855-3168; jmattingly@mclean.harvard.edu

Sarah Howie, BS

CONTACT

617-855-3168; showie1@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: January 28, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (5)