Clinical trial NCT03926520: Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
Official title: Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Dementia
Agitation,Psychomotor
Keywords: ECT
Agitation
Alzheimer's
Dementia
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Pine Rest Christian Mental Health Services
name: Emory University
name: The Zucker Hillside Hospital
name: Medical University of South Carolina
First posted: 2019-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: CMAI total score
timeFrame: The CMAI will be collected through study completion, about 13 months
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
timeFrame: The ADCS-CGIC will be collected for one month
measure: Neuropsychiatric Inventory, Clinician Version (NPI-C)
timeFrame: The NPI-C will be collected for one month
measure: Pittsburgh Agitation Scale (PAS)
timeFrame: The PAS will be collected for one month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pine Rest Christian Mental Health Services
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Glen Oaks
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Mclean Hospital
name: Brent P Forester, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: George Petrides, MD
role: PRINCIPAL_INVESTIGATOR
References: