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

Brent Forester

Status: Enrolling

Conditions: Alzheimer Dementia; Agitation,Psychomotor

Treatments: Device: Electroconvulsive Therapy (ECT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03926520

2020P002276

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ECT+UC group

Experimental group

Description:

ECT with Usual Care

Treatment:

Device: Electroconvulsive Therapy (ECT)