A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits

Mobile platforms have been leveraged in a variety of industries to drive dramatic efficiency gains. The technology enables redesign of key processes allowing for the more efficient use of labor and capital leading to better performance outcomes. Telehealth is the use of electronic information and mobile telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Much of the focus for the Institute of Medicine and other government agencies has been the application of telehealth to improve access to healthcare and specialized expertise by extending the reach of scarce resources to underserved populations. These platforms are also routinely deployed as disease management tools. A natural extension of these aims is the use of telehealth in the clinical development process, where both improved efficiency and the ability to be more inclusive of a broader patient population are critical steps in modernizing the clinical trial. REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from between 9 and 11 qualified Radiant Clinical Research primary care physicians (PCP), coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit. A 60-day interval is required between Visits 2 and 3 to reduce learning effects commonly observed with repeated administration of cognitive assessments.