How Decentralized Clinical Trials Made a Global Alzheimer's Trial Possible during the Pandemic

ABSTRACT

Background/Objective: The COVID-19 pandemic threatened the future of many clinical trials, including a global Phase III clinical trial focused on preclinical Alzheimer's disease. To retain participants in this fragile patient population, despite the restrictions of the pandemic, decentralized clinical trial (DCT) methods were adopted, including the participation of mobile research nurses to execute home visits Design: The trial required one-hour intravenous (IV) infusions every month for 4.5 years during the double-blind treatment period, with the option for an additional four years during the open-label treatment period. Investigational product (IP) was shipped to participants and reconstituted by mobile research nurses. Project management teams coordinated IP delivery and ancillary infusion supplies, separating logistics from clinical responsibilities. The same nurses were assigned to participants to create familiarity and comfort. Result(s) To date, more than 900 home visits have been conducted and 889 infusions completed. Patients were accepting of receiving infusions at home at a rate higher than the sponsor had anticipated at the outset of the pandemic. Visits began within seven weeks from the time of project kickoff. Conclusion(s) Patient interest and comfort with having nurses infuse them at home kept them on regimen and compliant to a demanding protocol, despite the challenges of the pandemic. Demand for DCTs has continued to increase, even after COVID-19 fears have subsided somewhat.