Implementation of Home Infusions in a Multinational Preclinical Alzheimer’s Disease Study

Abstract

AbstractBackgroundThe A4 Study is a Phase 3 clinical trial investigating solanezumab in preclinical Alzheimer’s disease. The COVID‐19 pandemic impacted the delivery of elective health services worldwide and social distancing restrictions created challenges for clinical trial participants to continue monthly infusions. In an effort to retain A4 participants, decentralized clinical trial methods were implemented, including deployment of mobile research nurses to conduct home visits.MethodThe A4 Study is a 4.5 year double‐blind trial, followed by an optional 4 year open‐label treatment period. The study launched in 2014 and 1163 males and females between the ages of 65 and 85 years old have been dosed. Home visits were not originally included in the study protocol, but were implemented in 2020 to mitigate the COVID‐19 pandemic impact on study conduct. PCM Trials offered home visits as an option to allow participants to continue to receive investigational product. Mobile research nurses traveled to participant homes and administered the 30‐ to 60‐minute intravenous infusions every 4 weeks.ResultTo date, more than 1,400 home infusions visits have been conducted in the A4 Study. 124 participants were enrolled in home infusions (99 in the United States; 1 in Canada and 24 in Australia) from 18 sites.ConclusionImplementation of home visits led to several positive outcomes, including reduced participant burden (particularly for participants living in rural/remote locations), study continuity and maintenance of treatment regimen, and retention of participants. Considering the length of the study, the infusion frequency, and the age of the participants, home visits have been a valuable option to help study completion and compliance. Data integrity and participant safety were ensured and maintained with the use of home visits in the A4 study.