Cognitive assessment with cognivue clarity®: psychometric properties and enhanced normative ranges in a diverse population

Background Detecting cognitive impairment in clinical practice is challenging as most instruments do not perform well in diverse samples of older adults. These same instruments are often used for eligibility into clinical trials making it difficult to recruit minoritized adults into Alzheimer’s disease (AD) studies. Cognivue Clarity ® is an FDA-cleared computerized cognitive screening platform using adaptive psychophysics to detect cognitive impairment. Objective Test the ability of Cognivue Clarity to detect cognitive impairment in a diverse community sample compared with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Methods This study enrolled 452 participants across 6 US study sites and completed both Cognivue Clarity device and RBANS. Psychometric properties and exploratory factor analysis of Cognivue Clarity were explored and comparisons against RBANS across different age, sex, education, and ethnoracial groups were conducted. Results Participants had a mean age of 47.9±16.1 years (range: 18-85), 63.6% were female, 45.9% had <12 years of education, 31.2% were African American and 9.2% were Hispanic. Cognivue Clarity had strong internal consistency, test-retest and minimal practice effects. A 4-factor structure (Memory, Attention, Visuomotor, and Discrimination) had excellent goodness of fit. Normalizing age effects improved performance. Race and education effects were similar to those seen with RBANS. Cognivue Clarity had strong correlation with RBANS. Conclusions Our study supports the use of Cognivue Clarity as an easy-to-use, brief, and valid cognitive assessment that can be used for identifying individuals with likely cognitive impairment in the clinical setting and those who could be candidates for AD research studies. ### Competing Interest Statement Dr. Galvin is Chief Scientific Officer for Cognivue, Inc and receives consulting fees. Dr. Chang received consulting fees from Cognivue, Inc. Paul Estes, Heather Harris, and Dr. Fung are employees of Cognivue, Inc. The authors take full responsibility for the data,; and have the right to publish all data ### Funding Statement Cognivue, Inc ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The FOCUS study was deemed exempt by the Advarra Institutional Review Board (Pro00064617). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The dataset for this project is available to all interested parties. Please contact JEG at jeg200{at}miami.edu. [1]: http://ClinicalTrials.gov