Utilization of home nursing to mitigate the impact of COVID-19 on the Conduct of the Gantenerumab Graduate Trials

Objective: This study evaluated the utilization of home administration of the study drug in the Phase III trials GRADUATE I and II (NCT03444870;NCT03443973), intended to avoid anticipated study drug non-compliance due to COVID-19 and thus preserve study integrity. Background: COVID-19 has impacted clinical study conduct significantly, particularly in Alzheimer's disease, which includes an aged population with increased comorbidities. Perceived risk of infection by traveling to a clinic, together with widespread clinical site closures and movement restrictions, reduced study drug compliance. Design/Methods: The GRADUATE studies are ongoing and will evaluate gantenerumab versus placebo administered subcutaneously. The protocol allows home administration for consenting participants. After the COVID-19 outbreak, home nursing scope was expanded. Uptake of home nursing administration prior to and during different phases of the pandemic was analyzed. Results: From March 2019-February 2020, 94 participants from 11 of 31 countries utilized home nursing, contributing to an average of approximately 35 home nursing visits per month. Between March-August 2020, this increased to 234 participants actively utilizing home nursing in 15 countries and an average of approximately 300 monthly visits. The highest peak in uptake was observed between March-April 2020. Conclusions: Expanding the availability of home nursing in GRADUATE in response to the COVID-19 pandemic resulted in a large and rapid increase in uptake-likely facilitated by gantenerumab's subcutaneous route of administration. Expanding home administration helped to preserve study integrity by reducing the risk of study drug non-compliance, compared to the usual reliance upon administration at sites, many of which closed or were inaccessible to study participants. Such benefits of home administration could extend beyond clinical trials to the real world, once drugs are approved, by giving patients more choice and flexibility in how to access gantenerumab.