SUPERIOR TEST-RETEST RELIABILITY OF COGNITIVE ASSESSMENT WITH COGNIVUE® VS SLUMS DURING AN 18-MONTH LONGITUDINAL STUDY

Abstract

Introduction Cognivue is an FDA-cleared computerized testing tool designed to assess early signs of cognitive impairment. In an FDA clearance study, Cognivue demonstrated good agreement with St. Louis University Mental Status (SLUMS) and other neuropsychological tests, and superior test re-test reliability compared to SLUMS across 2 sessions, 1 to 2 weeks apart (Cognivue regression fit: R2= 0.81, r= 0.90); SLUMS regression fit: R2 = 0.67, r= 0.82). Further follow up long-term data analysis within this cohort was done to study Cognivue's test re-test reliability vs SLUMS over time. Methods 238 subjects from the FDA clearance study enrolled in the longitudinal study. They underwent the Cognivue test and SLUMS at 3 sessions over the course of 18 months (6, 12, 18 months post-FDA study). An analysis of rank linear regression test-retest reliability was performed for both tests. In a separate sub-analysis, the medical records of those subjects were analyzed to determine the correlation, if any, between comorbidities or medication usage and Cognivue score. Results Among these 238 patients, Cognivue demonstrated similar linear regression scores across comparisons (test session 1&2: regression fit: R2= 0.76; r = 0.87; test session 1&3: regression fit: R2= 0.72; r = 0.85; test session 1&4: regression fit: R2= 0.73; r = 0.86). The SLUMS test demonstrated greater variability in regression scores across test sessions (test session 1&2: regression fit: R2= 0.63; r = 0.79; test session 1&3: regression fit: R2= 0.43 r = 0.65; test session 1&4: regression fit: R2= 0.64; r = 0.80). In the subanalysis, medical records of 203 subjects were analyzed. Overall, an increased co-morbidity count significantly decreased subjects’ Cognivue scores (correlation -0.21; P=0.01). Cardiopulmonary comorbidities had the largest impact on a patient's Cognivue score (78.0 score for those without this comorbidity vs 67.1 score for those with; P Conclusions Cognivue demonstrated maintained superior test re-test reliability compared to SLUMS over a period of 18 months after the FDA clearance study. An increased comorbidity count and cardiopulmonary comorbidities significantly decreased a subject's Cognivue score over time. This research was funded by: Cognivue, Inc.