Development and validation of novel tests in the DCT drawing analysis platform for the detection of Alzheimer's Disease-related early cognitive impairment

Project Summary Abstract Early detection of AD and AD related dementias is critical for the development of novel therapeutic agents and for effective patient treatment and careDCT has created a platform able to detect subtle changes in behavior indicative of early cognitive impairment by using a digital pen to record drawing motions and automatically analyzing that data using a combination of artificial intelligence and neuropsychological analysisDCT has successfully launched its first test on the platformDCTclockTMwhich has been demonstrated to detect subtle cognitive change in early Alzheimer s DiseaseADand AD related dementias earlier than standard cognitive testscorrelate with known AD biomarkers such as amyloid and tau in preclinical AD subjectsand detect known APOE genetic risk in cognitively healthy participantsThe test is FDA cleared to market for general cognitive assessment and is currently used in multinational clinical trialsresearch initiativesand by practicing clinicians for patient careDCT is now conducting a study involvingparticipants ranging from cognitively healthy to demented to validate a tablet as input device for the drawing dataand to collect data on a set of novel tablet based drawing tasks includinga symbol taska visual retention taska trail making taska pathfinding taskand a visuoconstructional taskWe aim to analyze task data collected in the study to produce a set of easily deployablerapidcost effectiveand sensitive tests to be used as cognitive digital biomarkers in clinical trials for AD and AD related dementiasThe first aim is to develop novel cognitive measures from these additional tests and obtain preliminary validationExisting data will be split into training and testing setsThe training set will be analyzed to develop metricsfollowing an interpretable hierarchical analysis structure with low level drawing measurements combined in a set of composite scales tied to a cognitive concepti einformation processingand then further combined to obtain a simplescore for performance on the testThe testing set will be used to conduct preliminary validation consisting of a Receiver Operating Characteristic curve analysiscorrelation measures to existing neuropsychological testsand test retest reliability measurements to ensure repeat testing stabilityThe second aim is to implement the developed metrics in the commercial DCT platformRobust software will be created for the measurementstorageand display of the novel metricssetting a foundation to enable usage of the metrics by research and commercial partners Project Narrative Novel therapeutic agents for Alzheimer s disease rely on recruiting subjects who are in the earliest stages of pre symptomatic impairment and the ability to accurately monitor these subjectsThis project will produce a set of easily deployablesensitiverapidand cost effective tablet based tests to be used as cognitive digital biomarkers by future clinical trials to help enable the development of new efficacious treatments for Alzheimer s diseaseThe short testing time and ease of use of the technology could also enable primary care providers to detect individuals most at risk for preclinical Alzheimer s disease and other related dementias