Cognivue Clinical Data

Cognitive Assessment with Cognivue Clarity^®: Psychometric Properties and Normative Ranges in a Diverse Population³⁵

Authors: James E. Galvin, Lun-Ching Chang, Paul W. Estes, Heather M. Harris, Ernest Fung
Journal: Journal of Alzheimer’s Disease
Year Published: 2024

Key Findings: Supports the use of Cognivue Clarity^® as an easy-to-use, brief, and valid cognitive assessment that measure cognitive performance. In the correct clinical setting, Cognivue Clarity may identify individuals with likely cognitive impairment who could be candidates for AD research studies.

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Objective: Test the ability of Cognivue Clarity to measure cognitive performance in a diverse community sample compared with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Methods:

452 participants enrolled across 6 US study sites and completed both Cognivue Clarity device and RBANS
Psychometric properties and exploratory factor analysis of Cognivue Clarity were explored
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)
- 6% were female
- 9% had ≤12 years of education
- 2% were African American
- 2% were Hispanic
Cognivue Clarity had strong internal consistency, test-retest reliability 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 correlations with RBANS

Conclusion

Supports the use of Cognivue Clarity as an easy-to-use, brief, and valid cognitive assessment that measures cognitive performance
In the correct clinical setting, Cognivue Clarity may identify individuals with likely cognitive impairment who could be candidates for AD research studies

Validity, Reliability, and Psychometric Properties of a Computerized, Cognitive Assessment Test (Cognivue^®)⁷

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

Cognivue Clarity^® in the Detection of Biomarker-Confirmed Mild Cognitive Impairment and Alzheimer’s Disease³⁴

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

Advancing Computerized Cognitive Assessment with Cognivue: Enhanced Normative Range Data Sets from a Diverse Population Improve Sensitivity and Patient Profiling³¹

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.

Bridging the Assessment Gap: Newly Developed Neuropsychiatric Cognitive Assessments on the Cognivue Platform Show Strong Correlation with Traditional Gold Standard Tests²

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.

Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding Study (FOCUS)²⁹

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.

Community Pharmacists Expand Access to Cognitive Function Assessments with the Cognivue Clarity^® Device³⁰

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.

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