Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)

Completed · Not applicable

Conditions studied: Alzheimer Dementia, Agitation,Psychomotor

In brief

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.

Key facts

Study ID

NCT03926520

Run by

Brent Forester

People needed

41

Starts

2021-01-28

Expected to finish

2026-05-31

Last updated by the study team

2026-07-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Dementia, of the following subtypes,
• Alzheimer's dementia, according to NIA-AA Criteria for dementia
• 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
• 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

You may not qualify if…

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

Where it is running

• Emory Healthcare — Atlanta, Georgia, United States
• McLean Hospital — Belmont, Massachusetts, United States
• Pine Rest Christian Mental Health Services — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Northwell Health — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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