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Trial record 1 of 1 for:    2018P003142
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Electroconvulsive Therapy (ECT) for Agitation in Alzheimer's Dementia (AD)

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ClinicalTrials.gov Identifier: NCT03926520
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Mayo Clinic
Pine Rest Christian Mental Health Services
Emory University
The Zucker Hillside Hospital
Medical University of South Carolina
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Brief Summary:
This study will explore the efficacy of ECT treatments plus usual care (ECT+UC), relative to a placebo simulated ECT plus usual care (S-ECT+UC) in reducing severe agitation in patients with moderate to severe Alzheimer's Disease. The study will also determine the tolerability/safety outcomes of ECT+UC relative to S-ECT+UC.

Condition or disease Intervention/treatment Phase
Alzheimer Dementia Agitation,Psychomotor Device: Electroconvulsive Therapy (ECT) Other: Simulated Electroconvulsive Therapy (S-ECT) Not Applicable

Detailed Description:
This study is a single blind, randomized, Simulated-ECT (S-ECT) controlled trial of electroconvulsive therapy (ECT). The purpose is to determine the efficacy and safety of ECT for severe agitation in moderate to severe stage Alzheimer's Disease (AD), while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. The investigators will study only inpatients with severe agitation and moderate to severe dementia, associated with high care costs and poor quality of life, who typically have already failed prior trials of psychotropic medications. The first aim is to compare the relative efficacy of up to 9 ECT treatments plus usual care (ECT+UC) versus Simulated ECT (S-ECT+UC) in reducing severe agitation in 200 participants with moderate to severe AD. The second aim is to compare the relative tolerability/safety outcomes of ECT+UC versus S-ECT+UC in the same group of participants. The exploratory aim is to understand the stability of agitation reduction (CMAI) and global functioning (ADCS-CGIC) with assessments at 1,3, and 6 months following the acute phase, and then for a fourth visit 12 months after the acute phase. Establishing safety and efficacy of ECT for severe agitation in AD provides an opportunity to decrease long-term care placement, decrease the risk of mortality, decrease caregiver burden, and enhance quality of life for patients and their caregivers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Electroconvulsive Therapy Plus Usual Care Versus Simulated-ECT Plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ECT+UC group 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.

Sham Comparator: S-ECT+UC group Other: Simulated Electroconvulsive Therapy (S-ECT)
The participant is brought to the ECT suite for the length a session would normally take (approximately 2 hours). While in the ECT suite, conducting gel will be placed on the scalp of the S-ECT subjects to parallel the ECT procedures in the ECT active group. A Band-Aid will also be placed on the arm of the S-ECT subjects to parallel the Band-Aid placed at the IV site for the ECT active group. Participants will not be administered anesthesia.




Primary Outcome Measures :
  1. 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 than S-ECT. 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 :
  1. Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC) [ Time Frame: The ADCS-CGIC will be collected through study completion, about 13 months ]
    The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.

  2. Neuropsychiatric Inventory (NPI) [ Time Frame: The NPI will be collected for one month ]
    The NPI is composed of several domains in which subscores on frequency and severity will be derived. The higher the frequency and/or severity within each domain, the worse the condition of the patient.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Alzheimer's Dementia according to NIA-AA Criteria for dementia [55]
  2. MMSE < 15
  3. Cohen-Mansfield Agitation Inventory Short Version (CMAI) score of ≥4 on at least one item, a score of 3 on at least two items, or a score of 2 on at least three items.
  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
  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 Non-AD Dementia
  3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
  4. Current episode of Major Depressive Disorder (MDD)
  5. Active substance use disorder within past 6 months
  6. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926520


Contacts
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Contact: Emily P Kilpatrick, BA 617-855-3136 ekilpatrick@mclean.harvard.edu
Contact: Aniqa T Rahman, BA 617-855-3257 arahman@mclean.harvard.edu

Sponsors and Collaborators
Brent Forester
Mayo Clinic
Pine Rest Christian Mental Health Services
Emory University
The Zucker Hillside Hospital
Medical University of South Carolina
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Responsible Party: Brent Forester, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03926520    
Other Study ID Numbers: 2018P003142
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Brent Forester, Mclean Hospital:
ECT
Agitation
Alzheimer's
Dementia
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations