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

Primary Purpose

Alzheimer Dementia, Agitation,Psychomotor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroconvulsive Therapy (ECT)
Sponsored by
Brent Forester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Dementia focused on measuring ECT, Agitation, Alzheimer's, Dementia

Eligibility Criteria

40 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of Dementia, of the following subtypes,

    • Alzheimer's dementia, according to NIA-AA Criteria for dementia
    • Vascular dementia based on:
    • History consistent with insidious onset of illness and gradual clinical decline
    • MRI evidence of microvascular ischemic disease (microinfarcts)
    • Physical and neurological examination do not indicate current or prior stroke
    • Frontotemporal dementia
    • Dementia with Lewy Bodies
  2. MMSE ≤ 15
  3. Cohen-Mansfield Agitation Inventory Short Version (CMAI) score of ≥5 on at least one item of aggression or a physical nonaggressive item 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, intentional falling, screaming, making verbal sexual advances, and cursing or verbal aggression (items 1-11, 14, 15, 22-24).
  4. At least three failed pharmacological interventions from different drug classes (including antidepressants, antipsychotics, anticonvulsants, prazosin, and cannabinoids) at therapeutic doses (to be determined by clinical judgment) and duration of at least two weeks each to manage behavioral symptoms. These interventions may also include medications discontinued after 1 week due to tolerability concerns. Furthermore, medication trials that occur prior to admission to the hospital may count towards the three failed trials. The trials can be inpatient and/or outpatient. These trials can also be concurrent, such as using two medications from different classes for at least one week at the same time (i.e. polypharmacy).
  5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries
  6. Comprehension of English language
  7. Authorized legal representative able and willing to give informed consent
  8. Age 55 - 89 years old (inclusive)

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

Sites / Locations

  • Emory HealthcareRecruiting
  • McLean HospitalRecruiting
  • Pine Rest Christian Mental Health ServicesRecruiting
  • Mayo ClinicRecruiting
  • Northwell HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECT+UC group

Arm Description

Outcomes

Primary Outcome Measures

CMAI total score
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

Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
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 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 assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.

Full Information

First Posted
April 19, 2019
Last Updated
October 19, 2023
Sponsor
Brent Forester
Collaborators
Mayo Clinic, Pine Rest Christian Mental Health Services, Emory University, The Zucker Hillside Hospital, Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03926520
Brief Title
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
Acronym
ECT-AD
Official Title
Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brent Forester
Collaborators
Mayo Clinic, Pine Rest Christian Mental Health Services, Emory University, The Zucker Hillside Hospital, Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia, Agitation,Psychomotor
Keywords
ECT, Agitation, Alzheimer's, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECT+UC group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electroconvulsive Therapy (ECT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
CMAI total score
Description
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.
Time Frame
The CMAI will be collected through study completion, about 13 months
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
Description
The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.
Time Frame
The ADCS-CGIC will be collected for one month
Title
Neuropsychiatric Inventory, Clinician Version (NPI-C)
Description
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.
Time Frame
The NPI-C will be collected for one month
Title
Pittsburgh Agitation Scale (PAS)
Description
The PAS assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.
Time Frame
The PAS will be collected for one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Diagnosis of Dementia, of the following subtypes, Alzheimer's dementia, according to NIA-AA Criteria for dementia 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 Mini Mental Status Exam (MMSE) less than or equal to 15 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). At least one failed pharmacological intervention to manage behavioral symptoms Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated Comprehension of English language Authorized legal representative able and willing to give informed consent Age 40 and above Exclusion Criteria: Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis 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 Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder Active substance use disorder within past 6 months Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jefferson Mattingly, BA
Phone
617-855-3168
Email
jmattingly@mclean.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria DelPico, BS
Phone
617-855-3168
Email
mdelpico@mclean.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent P Forester, MD, MSc
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Petrides, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeriya Tsygankova
Email
valeriya.tsygankova@emory.edu
First Name & Middle Initial & Last Name & Degree
Adriana Hermida, MD
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jefferson Mattingly, BA
Email
jmattingly@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Brent P Forester, MD, MSc
Facility Name
Pine Rest Christian Mental Health Services
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Holzgen
Email
Olivia.Holzgen@pinerest.org
First Name & Middle Initial & Last Name & Degree
Louis Nykamp, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Williams
Email
Williams.Sarah2@mayo.edu
First Name & Middle Initial & Last Name & Degree
Maria I Lapid, MD
Facility Name
Northwell Health
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heela Azizi
Email
hazizi@northwell.edu
First Name & Middle Initial & Last Name & Degree
Georgios Petrides, MD

12. IPD Sharing Statement

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

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