ECT-AD: Benefits and challenges of conducting a multisite NIH-funded clinical trial in a vulnerable population

Abstract

Over 90% of individuals with Alzheimer's disease (AD) experience agitation which increase morbidity and mortality and contribute to caregiver burden. There are no FDA-approved treatments for severe agitation in people with advanced dementia. Psychotropic medications used off-label have limited efficacy and risk for adverse effects. Behavioral interventions are not effective in the most severely agitated patients. New management strategies for severe agitation in AD refractory to psychopharmacologic and behavioral interventions are timely and warranted. Preliminary studies provide evidence for the safety and efficacy of acute electroconvulsive therapy (ECT) in reducing agitation in this population. In this session we will describe lessons learned so far in the process of creating a multisite research consortium, designing a single blind, randomized clinical trial of ECT to determine efficacy and safety for severe agitation in advanced AD, applying for NIH grant, navigating regulations at the local, state, and federal level, and overcoming challenges with study implementation.