Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 8. Age 40 and above Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Electroconvulsive Therapy (ECT)

Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia.

Locations (5)

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