Cognivue Clinical Data

FDA Clearance Study
Authors: Diego Cahn-Hidalgo, Paul W Estes, Reina Benabou
Journal: World Journal of Psychiatry
Year Published: 2020

Key Findings: Cognivue demonstrates good agreement with and superior reliability vs the St. Louis University Mental Status (SLUMS, references standard) test. Results of this study were used by FDA for Cognivue device clearance.

+ View More – View Less

Objective: To determine cut-off scores for classification of cognitive impairment and assess Cognivue safety and efficacy in a large validation study.
Population: Adults 55 to 95 years of age from assisted and independent-living communities who were at risk for age-related cognitive decline or dementia

Cut-off score determination study:

  • 92 subjects were administered the SLUMS and Cognivue tests at 1 of 5 sites
  • Optimization analyses by positive percent agreement (PPA) and negative percent agreement (NPA), and by accuracy and error bias were conducted

Validation study:

  • 401 subjects completed ≥1 testing session, and 358 completed 2 sessions 1 to 2 weeks apart
  • Regression, rank linear regression, and factor analyses were conducted

Cut-off score determination study:

  • Cognivue scores of 54.5 (NPA = 0.92; PPA = 0.64; impairment) and 78.5 (NPA = 0.5; PPA = 0.79; no impairment) correspond to SLUMS cut-off scores of < 21 and > 26, respectively

Validation study:

  • Cognivue classification scores were validated, demonstrating good agreement with SLUMS scores (weighted K 0.57; 95%CI: 0.50-0.63)
  • Reliability analyses showed similar scores across repeated testing for Cognivue (R2 = 0.81; r = 0.90) and SLUMS (R2 = 0.67; r = 0.82)

Cut-off score determination study:

  • Cognivue® scores established to avoid misclassification of impairment

Validation study:

  • Good agreement between Cognivue and SLUMS
  • Superior reliability vs SLUMS
  • Good psychometric validity

Authors: John Andrefsky, Diego Cahn-Hidalgo, Reina Benabou, Fred Ma
Journal: Neurological Sciences and Neurosurgery
Year Published: 2021

Key Findings: Cognivue demonstrated superior reliability vs SLUMS over 18 months

+ View More – View Less

Objective: To compare the test-retest reliability of Cognivue with that of the SLUMS test over the course of 18 months
Population: Subjects from the FDA pivotal clinical trial, who were adults (55-95y) from independent-living communities at risk for age-related cognitive decline or dementia


  • 238 subjects from the FDA-regulated clinical study for device clearance were included in the longitudinal study
  • Subjects underwent the Cognivue test and SLUMS at 3 sessions over the course of 18 months (6, 12, 18 months post-FDA study)
  • Test-retest reliability was determined through analysis of the correlation (r) and linear regression (r2) between variables
  • 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


  • 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, an increased co-morbidity count significantly decreased subjects’ Cognivue scores (correlation -0.21; P=0.01)
    • Cardiopulmonary comorbidities had a significant impact on a patient’s Cognivue score (P<0.001)


  • Cognivue demonstrated maintained superior test re-test reliability compared to SLUMS over up to 5 test sessions in a period of 18 months
  • An increased comorbidity count and cardiopulmonary comorbidities significantly decreased a subject’s Cognivue score.