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.

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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 Sciences and Neurosurgery
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.

Authors: James E. Galvin, MD, MPH; Michael J. Kleiman, PhD; Heather M. Harris; Paul W. Estes
Conference Poster:The American Academy of Neurology (AAN) Annual Meeting
Year Presented: 2024

Key Findings: Cognivue Clarity® discriminated healthy controls from those with Mild Cognitive Impairment (MCI) and Alzheimer’s disease (AD), strongly correlated with AD biomarkers, and had strong psychometric properties.
Data is also published in Neurology, Volume 102, Number 17 Supplement 1, 2024. View it in Neurology

Authors: James E. Galvin, MD, MPH, Joel Raskin, MD, Paul Estes, Robert Parody PhD, Catherine Tallmadge, Heather Harris
Conference Poster: Clinical Trials for Alzheimer’s Disease (CTAD) Annual Conference
Year Presented: 2023

Key Findings: Cognitive assessment with Cognivue Clarity® among a diverse population of study participants enhances normative range data sets to improve sensitivity and patient profiling.
Data is also published in The Journal of Prevention of Alzheimer’s Disease, Volume 10, Supplement 1, 2023. View it in The Journal of Prevention of Alzheimer’s Disease, page 225.

Authors: : James E. Galvin, MD, MPH, Paul Estes, Shiva Pal, Seth Wideman, Catherine Tallmadge, Heather Harris
Conference Poster: Clinical Trials for Alzheimer’s Disease (CTAD) Annual Conference
Year Presented: 2023

Key Findings: Cognitive assessment with the computerized Cognivue Clarity® device showed strong correlation with traditional gold-standard cognitive tests and excellent internal consistency and reliability.
Data is also published in The Journal of Prevention of Alzheimer’s Disease, Volume 10, Supplement 1, 2023. View it in The Journal of Prevention of Alzheimer’s Disease, page 169.

Authors: James E. Galvin, MD, MPH; Velocity Clinical Research; Paul W. Estes; Heather M. Harris
Conference Poster: Alzheimer’s Association International Conference (AAIC)
Year Presented: 2023

Key Findings: Historically underserved and underrepresented populations have a 37% research participation rate in the FOCUS cognitive testing study in the United States (US).
Data is also published in Alzheimer’s & Dementia, Volume 19, Issue S24, Supplement: Developing Topics December 2023. View it in Alzheimer’s & Dementia.

Authors: Amina Abubaka, PharmD, AAHIVP; Saswat Kabisatpathy, PharmD; Susan Lutz; Jessica Sinclair, PharmD
Conference Poster: Alzheimer’s Association International Conference (AAIC)
Year Presented: 2023

Key Findings: With training and use of the Cognitive Clarity® device, pharmacists can easily provide an objective cognitive function assessment. Widespread implementation of pharmacy-based computerized cognitive testing could greatly expand access to meet the brain health needs of the growing senior population including patients living in medically underserved and rural areas.
Data is also published in Alzheimer’s & Dementia, Volume 19, Issue S24, Supplement: Developing Topics December 2023. View it in Alzheimer’s & Dementia.

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.

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.

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.

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.