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
- Diseases
- Alzheimer disease
- 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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Glen Oaks | United States | Unknown status |
| Pine Rest Christian Mental Health Services Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.