May 2, 2022
IMPACT members, Fan Li, PhD, Monica Taljaard, PhD, Spencer Hey, PhD, and Susan Mitchell, MD, MPH, a principal investigator of the IMPACT Collaboratory are among the authors of this literature review on the ethics of randomized controlled trials in the context of Alzheimer’s disease and related dementias. The article was published by Alzheimer’s & Dementia: Translational Research & Clinical Interventions (TRCI) on May 2.
The literature review describes the landscape of pragmatic randomized controlled trials in the context of Alzheimer’s disease and related dementias with respect to ethical considerations. Authors reviewed information related to trial setting, interventions, data collection, study population, and ethical protections (including ethics approvals, capacity assessment, and informed consent) in 62 eligible reports of trials specifically focused on people living with dementia or their caregivers between January 2014 and April 2019. The goal was to learn about the challenges posed by ethical concerns related to conducting pragmatic RCTs in AD/ADRD. The main objectives were to describe: Trial characteristics, study populations and prevalence of reporting of ethical protections. They found that few studies reported protections implemented for vulnerable participants. Shortcomings remain when reporting consent approaches and capacity assessment.