Cognivue Clinical Data : Cognivue

Cognivue Clinical Data

Cognivue Clarity Characterizes Mild Cognitive Impairment and Alzheimer’s Disease in Biomarker Confirmed Cohorts in the Bio-Hermes Study³⁹

Authors: James E. Galvin, Michael J. Kleiman, Paul W. Estes, Heather M. Harris, Ernest Fung
Journal: Scientific Reports
Year Published: 2024

Key Findings: Demonstrates Cognivue Clarity^®’s ability to reliably differentiate between the cognitively normal, MCI, and mild dementia groups regardless of amyloid status. Therefore, it can provide useful information for consideration for further evaluation with biomarkers and more detailed neuropsychological evaluation in both clinical research and clinical practice settings.

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Objective: Examine the ability of Cognivue Clarity to (a) detect MCI and AD in clinical diagnostics groups, (b) determine the presence of amyloid, and (c) distinguish between biomarker-confirmed groups.

Study Design:

887 of enrolled participants completed both Cognivue Clarity and amyloid PET scans
Participants were placed into 1 of the 3 cohorts: Cognitively Normal (388); MCI (282); Probable Mild AD (217)
Significant representation of racial and ethnic minority participants: 78.8% non-Hispanic White; 9.6% Black; 9.8% Hispanic; and 1.8% Asian

Results Summary :

Cognivue Clarity had good sensitivity, reliably detecting the presence of MCI and AD (clinical diagnosis sample), and MCI due to AD or AD dementia (biomarker-confirmed sample)
Cognivue Clarity had good negative predictive value, reliably identifying Cognitively Normal individuals (clinical diagnosis sample) and True Controls (biomarker-confirmed sample)
Cognivue Clarity differentiated individuals with amyloid from individuals without amyloid
Compared with the MMSE and RAVLT, only Cognivue Clarity could differentiate MCI due to AD from non-AD causes of MCI
Cognivue Clarity performed equally well across all ApoE genotypes in both impaired and non-impaired participants
Performance in impaired individuals was not different by ethnoracial identity
Cognivue Clarity had medium to large effect sizes and moderate correlations with other imaging and plasma AD biomarkers, similar to the strength of association of the AD biomarkers with each other

Main Takeaways

Cognivue Clarity reliably detected cognitive impairment in clinical and biomarker-confirmed samples
Cognivue Clarity differentiated between cognitively normal, MCI, and dementia groups regardless of amyloid status
With support of statistically significant findings—Cognivue Clarity captured most individuals with cognitive impairment, and excluded most individuals who are cognitively normal—Cognivue Clarity can provide useful information for consideration for further evaluation with biomarkers and detailed neuropsychological evaluation
Cognivue Clarity’s ability to differentiate MCI due to AD from AD, and between AD and non-AD forms of impairment has value to clinical research and real-world practice as AD treatments move to a more precision-based approach where differential treatment options (pharmacologic and non-pharmacologic) may require such distinction

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

The Cognivue Amyloid Risk Measure (CARM): A Novel Method to Detect the Presence of Amyloid in Clinical Samples with Cognivue Clarity^®40

Authors: James E. Galvin, MD, MPH; Michael J. Kleiman, PhD; Paul W. Estes; Heather M. Harris; and Ernest Fung, PsyD
Conference Poster: Clinical Trials on Alzheimer’s Disease Conference (CTAD)
Year Presented: 2024

Key Findings: Cognivue Clarity^® could be used to help screen older adults for treatment protocols with anti-amyloid therapies, enrich clinical trial recruitment before obtaining expensive biomarkers, and identify individuals likely to have preclinical AD for prevention studies in a valid, brief, and cost-effective fashion. View it in The Journal of Prevention of Alzheimer’s Disease, page 201.

Detection of Amyloid Status and Preclinical Alzheimer’s Disease Using Cognivue Clarity^®, An Adaptive Psychophysics Computerized Cognitive Battery in The Bio-Hermes Study³⁶

Authors: James E. Galvin, MD, MPH; Michael J. Kleiman, PhD; Paul W. Estes; Ernest Fung, PsyD; and Heather M. Harris
Conference Poster:The Alzheimer’s Association International Conference (AAIC)
Year Presented: 2024

Key Findings: Cognivue Clarity^® has great potential as an enrichment strategy for Alzheimer’s disease (AD) clinical trials testing amyloid-lowering therapies as well as for AD prevention.

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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