Technology and Remote Assessment Core

ABSTRACT – ALLFTD2: TECHNOLOGY AND REMOTE ASSESSMENT CORE Until recently, most observational studies have required in-person participation, often with visits spaced one or more years apart. Although these projects have been successful, there are also limitations. For example, clinical trials collect data quarterly or biannually, limiting the usefulness of annually collected data for the simulation exercises needed to design FTLD clinical trials. The time and resources required to travel for multiday in-person visits also present a barrier to participation. To address these concerns, ALLFTD investigators piloted digital health technologies (DHT) during the current cycle, including a smartphone-based platform (ALLFTD Mobile App [mApp]) for remotely deploying clinical outcome assessments and cognitive tests. We successfully enrolled over 500 participants during the last cycle to complete these smartphone tasks. Preliminary studies conducted in this cohort demonstrated that remote digital data collection was acceptable and feasible, and that the data collected were of high quality, reliable, and produced results that were similar to gold-standard measures collected in person. ALLFTD has also partnered with the FTD Disorders Registry (Registry) to collect data and support participant communication and engagement. ALLFTD2 will organize the implementation of remote monitoring within a new Technology and Remote Assessment Core (TRAC) that will support the goals of Projects 1 and 2 to develop these remote methods and DHTs for use in clinical trials. TRAC will oversee remote collection of well-established tasks that capture executive function and memory using the ALLFTD mApp and process these data to extract validated metrics in support of the project goals. TRAC will develop new methods to characterize cognition and function using speech samples and smartphone sensors, and work with ALLFTD biostatistical experts to apply robust methods to extract and validate a range of innovative metrics from these data. TRAC will expand remote diagnostic and functional assessments by creating a remote clinical assessment team (RCAT). We will also oversee remote blood collection to allow more frequent biomarker sampling. TRAC will build upon ALLFTD’s partnership with the Registry to improve participant engagement and communication, collect participant feedback, and create new tools for participants, study sites, and track participant status.