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

NCT03926520 · Mclean Hospital
In plain English

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Official title
Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
About this study
This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.
Eligibility criteria
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
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-01-28
Estimated completion: 2025-05-31
Last updated: 2024-06-03
Interventions
Device: Electroconvulsive Therapy (ECT)
Primary outcomes
  • CMAI total score (The CMAI will be collected through study completion, about 13 months)
Sponsor
Brent Forester · other
With: Mayo Clinic, Pine Rest Christian Mental Health Services, Emory University, The Zucker Hillside Hospital, Medical University of South Carolina
Contacts & investigators
ContactJefferson Mattingly, BA · contact · jmattingly@mclean.harvard.edu · 617-855-3168
ContactSarah Howie, BS · contact · showie1@mgb.org · 617-855-3168
InvestigatorBrent P Forester, MD, MSc · principal_investigator, Mclean Hospital
InvestigatorGeorge Petrides, MD · principal_investigator, Northwell Health
All locations (5)
Emory HealthcareRecruiting
Atlanta, Georgia, United States
McLean HospitalRecruiting
Belmont, Massachusetts, United States
Pine Rest Christian Mental Health ServicesRecruiting
Grand Rapids, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Northwell HealthRecruiting
Glen Oaks, New York, United States
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) · TrialPath