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Not recruiting

ECT

Sponsor:

Brent Forester

Code:

NCT03926520

Conditions

Alzheimer Dementia

Agitation,Psychomotor

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Electroconvulsive Therapy (ECT)

Study Details

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

Study ID

NCT03926520

Start date

Jan 28, 2021

Status verified date

Jul, 2026

Completion date

May 31, 2026

Primary completion date

May 31, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Diagnosis of Dementia, of the following subtypes,

1. Alzheimer's dementia, according to NIA-AA Criteria for dementia
2. 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
2. Mini Mental Status Exam (MMSE) less than or equal to 15
3. 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).
4. At least one failed pharmacological intervention to manage behavioral symptoms
5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated
6. Comprehension of English language
7. Authorized legal representative able and willing to give informed consent
8. Age 40 and above

Exclusion Criteria:

1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (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 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
3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
4. Active substance use disorder within past 6 months
5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months

Study Design

Enrollment

41 participants

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ECT+UC group

ECT with Usual Care

Interventions

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.

Primary outcome measure

  • CMAI total score [ Time Frame: The CMAI will be collected through study completion, about 13 months ]

Central Contacts and Locations

More Information

Sponsor

Brent Forester

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • ECT
  • Agitation
  • Alzheimer's
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Brent Forester on 2026-07-30.