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

Alzheimer Dementia Clinical Trial

— ECT-AD  

Official title:

Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926520
• Other study ID #: 2020P002276
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Mclean Hospital
• Contact: Jefferson Mattingly, BA
• Phone: 617-855-3168
• Email: jmattingly[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Alzheimer Dementia
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Device:
• Electroconvulsive Therapy (ECT)
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.

Locations

Country	Name	City	State
United States	Emory Healthcare	Atlanta	Georgia
United States	McLean Hospital	Belmont	Massachusetts
United States	Northwell Health	Glen Oaks	New York
United States	Pine Rest Christian Mental Health Services	Grand Rapids	Michigan
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Brent Forester	Emory University, Mayo Clinic, Medical University of South Carolina, Pine Rest Christian Mental Health Services, The Zucker Hillside Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The CMAI will be collected through study completion, about 13 months
Secondary	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.	The ADCS-CGIC will be collected for one month
Secondary	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.	The NPI-C will be collected for one month
Secondary	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.	The PAS will be collected for one month