Abstract Details

Title Cognivue Clarity® in the Detection of Biomarker Confirmed Mild Cognitive Impairment and Alzheimer’s Disease

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-008

Objective

Demonstrate the utility of Cognivue Clarity as a digital biomarker of mild cognitive impairment (MCI) and Alzheimer’s disease (AD).

Background AD and MCI treatment and prevention trials are underway; however, recognition of potentially eligible individuals can be challenging which leads to delayed recruitment and high screen failure. Digital biomarkers that can accurately identify MCI and AD and correspond to AD biomarkers could greatly facilitate enrollment and track disease progression and/or response to treatment. Cognivue Clarity is an FDA-cleared 10-minute, digital cognitive testing platform using adaptive psychophysics to capture global and domain-specific performance.

Design/Methods The Bio-Hermes study, funded by the Global Alzheimer’s Platform, enrolled Healthy controls, MCI and AD. Assessments included sociodemographic, Cognivue Clarity, plasma AD biomarkers, and amyloid PET scans. Cognivue Clarity psychometric properties, diagnosis discrimination, correlations with AD biomarkers, and diagnostic power were analyzed.

Results

Cognivue Clarity was analyzed in 555 participants (297 Controls, 113 MCI, 145 AD) with a mean age of 71.9+6.6y, 15.6+2.8y of education, 56.4% female, 21.7% underrepresented minorities, a mean MMSE of 26.6+3.0, and a mean Cognivue Clarityscore of 64.0+17.4. Cronbach’s alpha was 0.882 (95%CI: 0.867-0.897) indicating high reliability. Cognivue Clarity average and subtest scores robustly differentiated (p<0.001) between healthy controls (71.9+12.5), MCI (60.1+16.2) and AD (49.4+17.4). Cognivue Clarity^®correlated with Aβ42/40 (r=.253, p<.001), Amyloid Probability Score (r=-.339, p<.001), Amyloid PET (r=-.486, p<.001), ptau217 (r=-.426, p<.001), and ptau181 (r=.-287, p<.001). Cognivue Clarityhad a positive likelihood ratio of 2.17, negative likelihood ratio of 0.29, and diagnostic odds ratio of 7.48.

Conclusions Cognivue Clarity discriminated healthy controls from MCI and AD, strongly correlated with AD biomarkers, and had strong psychometric properties. Individuals with Cognivue Clarity average scores <70 were 7.5-fold more likely to be impaired. Cognivue Clarity can be used to screen individuals for cognitive impairment, enrich clinical trial inclusion, and track disease progression.

Authors/Disclosures
Heather Harris, Other (Cognivue) PRESENTER	Ms. Harris has received personal compensation for serving as an employee of Cognivue. Ms. Harris has stock in Cognivue.
James E. Galvin, MD, MPH (University of Miami Miller School of Medicine)	Dr. Galvin has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cognivue. Dr. Galvin has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Biogen. Dr. Galvin has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eisai. Dr. Galvin has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Galvin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for GE Healthcare. Dr. Galvin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Galvin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PassageBio. The institution of Dr. Galvin has received research support from National Institutes of Health. Dr. Galvin has received intellectual property interests from a discovery or technology relating to health care. Dr. Galvin has a non-compensated relationship as a Board of Directors with Alzheimer Association Southeast Florida Chapter that is relevant to AAN interests or activities. Dr. Galvin has a non-compensated relationship as a Board of Directors with Lewy Body Dementia Association that is relevant to AAN interests or activities. Dr. Galvin has a non-compensated relationship as a Board of Directors with Lewy Body Dementia Resource Center that is relevant to AAN interests or activities.
Michael J. Kleiman, PhD (University of Miami Miller School of Medicine)	Dr. Kleiman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WellSaid.AI. Dr. Kleiman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cognivue.
Paul Estes	Paul Estes has received personal compensation for serving as an employee of Cognivue, Inc.

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