Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBrent Forester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Dementia, of the following subtypes,
Alzheimer's dementia, according to NIA-AA Criteria for dementia
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).
Disqualifiers
Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
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
Trial design
Design model
Single group
Treatments tested in this trial
Electroconvulsive Therapy (ECT)
DeviceStimulus 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: ECT+UC groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The CMAI will be collected through study completion, about 13 monthsSecondary outcomes
1
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.
Time frame
The ADCS-CGIC will be collected for one month2
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.
Time frame
The NPI-C will be collected for one month3
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.
Time frame
The PAS will be collected for one monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brent Forester
Lead sponsor
Mclean Hospital
Sponsor institution
Mayo Clinic
Collaborator
Pine Rest Christian Mental Health Services
Collaborator
Emory University
Collaborator
The Zucker Hillside Hospital
Collaborator
Medical University of South Carolina
Collaborator
Source ClinicalTrials.gov