Digital is the New Blood: Enabling the Present and the Future

AbstractBackgroundDigital is the new blood, where collection, use, and storage of raw digital data streams enabled by technology‐embedded sensors are replacing analog methods. Analyses of digital data extend beyond current applications, analogous to previously stored blood currently be used for omics/biomarker research. Today digital technologies are used to measure Alzheimer’s disease (AD)‐related clinical symptoms (e.g., cognition, function, and behavior), but future possibilities remain to be determined. Importantly, digital data collection can go beyond current intermittent sampling by employing internet‐connected applications and devices that allow real‐time monitoring and accurate detection of changes, even within a widely heterogeneous spectrum.MethodBeginning in 2005, the Framingham Heart Study (FHS) began digitally recording participants’ spoken responses to neuropsychological (NP) test questions, and in 2011 extended to a digital pen to record written responses. The emergence of wearable devices and smartphone applications has led to an expanded use of digital technologies beyond recordings during NP assessments. The Boston University Alzheimer’s Disease Research Center (BU ADRC) leverages digital sensors in multiple internet‐connected devices that longitudinally collect digital data, in both in‐person and remote settings.ResultThe first publication involving FHS digital data was in 2016; the remaining (n> 17) have been from 2020‐current. Digital data measuring cognition, function and behavior are being collected through the BU ADRC, where results to date indicate nearly 100% and 75% uptake of active and passive engagement applications, respectively, and 95% uptake for wearable devices (n = 60). Longitudinal assessments include > 3 months for ∼50 participants; > 1 year for n∼21 participants.ConclusionOpportunities for improved trial outcome measurement are evident in the broad range of outcomes digital sensors capture beyond traditional research methodologies. Digital tools are being deployed for rapid screening for clinical trial inclusion, but more transformative opportunities are still to come. Replacing the sporadic and highly heterogeneous measures of cognition and related behaviors with more accurate measures that track treatment impact in real‐time at the individual level will shift the concept of clinically meaningful outcomes from group indicators to personalized ones. Digital is central to the realization of virtual clinical trial monitoring for precision treatment effects.