Cognivue Clarity® characterizes amyloid status and preclinical Alzheimer's disease in biomarker confirmed cohorts in the Bio-Hermes Study.

Abstract

BackgroundCognivue Clarity^® is an FDA-cleared computerized cognitive test to screen for cognitive impairment included in the Bio-Hermes Study to test blood-based and digital biomarkers' ability to screen for mild cognitive impairment (MCI) and Alzheimer's disease (AD). A subset of cognitively normal individuals have amyloid deposition (Preclinical AD) but no current assessment can identify these individuals in the absence of expensive biomarkers.ObjectiveWe examined differences in Cognivue Clarity performance between amyloid positive and amyloid negative individuals and whether Cognivue Clarity could differentiate True Controls (cognitively normal/amyloid negative), Preclinical AD (cognitively normal/amyloid positive), and MCI due to AD (MCI-AD, cognitively impaired/amyloid positive).MethodsCognivue Clarity was administered to all participants in the Bio-Hermes Study who also had amyloid PET and blood-based biomarkers. Performance was compared between biomarker-defined groups: True Controls (n = 297), Preclinical AD (n = 95), and MCI-AD (n = 113).ResultsCognivue Clarity global scores distinguished amyloid positive individuals from amyloid negative individuals (p < 0.001) and differentiated True Controls versus Preclinical AD (p = 0.014) and Preclinical AD versus MCI-AD (p < 0.001). Three subtests [Shape Discrimination (p = 0.004), Visual Salience (p = 0.008), Adaptive Motor Control (p = 0.004)] and the 3-test mean (p < 0.001) differentiated True Controls from Preclinical AD. The 3-test composite correlated with Amyloid PET (r = -0.433) and pTau217 (r = -0.400). The 3-test mean identified Preclinical AD in both White and Black participants.ConclusionsCognivue Clarity, a 10-min computerized battery, screens for individuals with cognitive impairment, characterizes amyloid positive individuals, and identifies Preclinical AD. This has great potential as a cost- and time-effective strategy to screen and enroll in AD prevention trials.