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 patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies, 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 dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. 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 (Clinical Global Impression-Severity [CGI-S]) with assessments at 1,3, and 6 months following the randomized phase, and then for a fourth visit 12 months after the randomized phase. Establishing safety and efficacy of ECT for severe agitation in dementias 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.
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 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 relative to S-ECT+UC.