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Shock therapy for dementia agitation? new trial tests ECT

NCT ID NCT03926520

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

41 people

The number who actually took part.

Started

Jan 2021

Finished

May 2026

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Emory Healthcare

    Atlanta, Georgia, 30308, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

  • Northwell Health

    Glen Oaks, New York, 11004, United States

  • Pine Rest Christian Mental Health Services

    Grand Rapids, Michigan, 49548, United States

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