Shock therapy for dementia agitation? new trial tests ECT
NCT ID NCT03926520
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether adding electroconvulsive therapy (ECT) to usual care can safely reduce severe agitation in people with moderate to severe dementia, including Alzheimer's and other types. Fifty participants will receive ECT sessions with anesthesia, and researchers will measure changes in agitation using a standard scale. The goal is to see if ECT can provide quick relief when other treatments have failed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Electroconvulsive therapy (ECT) using right unilateral electrode placement and ultra-brief pulse width
- What this could lead to
- If it works, this could offer a new option to quickly calm severe agitation in dementia patients who haven't responded to other treatments.
- What could go wrong
- This is a small early study with only 50 participants, so results may not apply to everyone. ECT carries risks from anesthesia and possible memory side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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41 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory Healthcare
Atlanta, Georgia, 30308, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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McLean Hospital
Belmont, Massachusetts, 02478, United States
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Northwell Health
Glen Oaks, New York, 11004, United States
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Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548, United States
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