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

Not Applicable

Recruiting

• Conditions: Alzheimer Dementia; Agitation,Psychomotor
• Interventions: Device: Electroconvulsive Therapy (ECT)

• Registration Number: NCT03926520
• Lead Sponsor: Brent Forester

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.

Study Timeline

• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2021-01-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECT+UC group	Electroconvulsive Therapy (ECT)	ECT with Usual Care

Primary Outcome Measures

Name	Time	Method
CMAI total score	The CMAI will be collected through study completion, about 13 months	The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)	The ADCS-CGIC will be collected for one month	The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.
Neuropsychiatric Inventory, Clinician Version (NPI-C)	The NPI-C will be collected for one month	The NPI-C is an improved version of the NPI composed of several domains of which we will use Agitation and Aggression, as well as their sum. The higher the frequency and/or severity within each domain, the worse the condition of the patient.
Pittsburgh Agitation Scale (PAS)	The PAS will be collected for one month	The PAS assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.

Trial Locations

Locations (5)

Emory Healthcare; 🇺🇸 Atlanta, Georgia, 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

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States