NCT03926520 · RECRUITING
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
This trial is testing whether electroconvulsive therapy (ECT) — brief, controlled electrical stimulation of the brain — can safely reduce severe agitation in people with moderate to severe dementia, including Alzheimer's. It is a Phase NA (non-randomized feasibility or pilot) study, meaning researchers are still working out whether this approach is safe and practical enough to study further. It is not testing a drug.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-28