- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926520
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) (ECT-AD)
Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jefferson Mattingly, BA
- Phone Number: 617-855-3168
- Email: jmattingly@mclean.harvard.edu
Study Contact Backup
- Name: Maria DelPico, BS
- Phone Number: 617-855-3168
- Email: mdelpico@mclean.harvard.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory Healthcare
-
Contact:
- Valeriya Tsygankova
- Email: valeriya.tsygankova@emory.edu
-
Principal Investigator:
- Adriana Hermida, MD
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- Recruiting
- McLean Hospital
-
Contact:
- Jefferson Mattingly, BA
- Email: jmattingly@mclean.harvard.edu
-
Principal Investigator:
- Brent P Forester, MD, MSc
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49548
- Recruiting
- Pine Rest Christian Mental Health Services
-
Contact:
- Olivia Holzgen
- Email: Olivia.Holzgen@pinerest.org
-
Principal Investigator:
- Louis Nykamp, MD
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Sarah Williams
- Email: Williams.Sarah2@mayo.edu
-
Principal Investigator:
- Maria I Lapid, MD
-
-
New York
-
Glen Oaks, New York, United States, 11004
- Recruiting
- Northwell Health
-
Contact:
- Heela Azizi
- Email: hazizi@northwell.edu
-
Principal Investigator:
- Georgios Petrides, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ECT+UC group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CMAI total score
Time Frame: 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.
|
The CMAI will be collected through study completion, about 13 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
Time Frame: 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.
|
The ADCS-CGIC will be collected for one month
|
Neuropsychiatric Inventory, Clinician Version (NPI-C)
Time Frame: 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.
|
The NPI-C will be collected for one month
|
Pittsburgh Agitation Scale (PAS)
Time Frame: 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.
|
The PAS will be collected for one month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brent P Forester, MD, MSc, McLean Hospital
- Principal Investigator: George Petrides, MD, Northwell Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P002276
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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