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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.
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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
Methods:
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
Results:
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)
Conclusion
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 Science and Neurosurger
Year Published: 2021
Key Findings: Cognivue demonstrated superior reliability vs SLUMS over 18 months
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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
Methods:
- 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
Results:
- 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)
Conclusion
- 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.
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Cognitive Stressors and COVID-19 Infection: A Longitudinal Survey9
Authors: Fred Ma, Ardeshir Hashmi, Charles Yu Liu, Heather Harris
Journal: Neurological Sciences and Neurosurgery
Year Published: 2022
Key Findings: Prevalence of stressors known to affect cognitive functioning has increased during the pandemic, underscoring the importance of cognitive testing.
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Clinical validation of Cognivue – a computerized alternative to the Montreal Cognitive Assessment10
Authors: Fred Ma, Diego Cahn-Hidalgo
Journal: Neurological Sciences and Neurosurgery
Year Published: 2021
Key Findings: Cognivue is as effective as MoCA while demonstrating better test-retest reliability. Cognivue also improves opportunities for timely, objective assessment of cognitive function and eliminates the biases.
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COVID-19 Related Stressors and the Role of Cognitive Assessment11
Authors: Fred Ma, Ardeshir Hashmi, Charles Yu Liu
Journal: Neurological ScienceS and Neurosurgery
Year Published: 2021
Key Findings: Prevalence of stressors known to affect cognitive functioning has increased during the pandemic, underscoring the importance of cognitive testing.
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Cognitive Impairment in Patients with Multiple Sclerosis as Assessed by Objective Computerized Testing12
Authors: Roberto Bompreszzi, Kerime Ararat, Evdokia Eleftheriou, Kara Smith, Reina Benabou
Journal: Neurological ScienceS and Neurosurgery
Year Published: 2020
Key Findings: Cognivue proved helpful in detecting multi-domain cognitive impairment in patients with multiple sclerosis.