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
Qualifiers
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
Treatments tested in this trial
- Electroconvulsive Therapy (ECT)
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
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