Fact CheckerSign in

NCT03926520Completed

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

Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
41 (actual)
First submitted
19 Apr 2019
Start date
28 Jan 2021
Primary completion date
31 May 2026
Lead sponsor
Brent Forester
NCT number
NCT03926520

What you commit to

  • Study type: Interventional
  • Participants enrolled: 41
  • From 28 Jan 2021 to the primary completion date, 31 May 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
  • Active substance use disorder within past 6 months

Other

  • Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis

Who the study is looking for

  • Diagnosis of Dementia, of the following subtypes,
    • Alzheimer's dementia, according to NIA-AA Criteria for dementia
    • Vascular dementia based on:
    • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory Healthcare
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesUnknown status
Northwell Health
Coordinator of this site? Confirm its status
Glen OaksUnited StatesUnknown status
Pine Rest Christian Mental Health Services
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.