Cognivue® to Partner on Another Major Clinical Study with the Global Alzheimer’s Platform Foundation
Cognivue Clarity®, a non-invasive and repeatable digital cognitive assessment tool that can assess cognitive functioning and amyloid presence, will be evaluated in the Bio-Hermes-002 study.
October 30, 2024
Cognivue, Inc. announces strategic partnership with the Global Alzheimer’s Platform (GAP) as we participate in the Bio-Hermes-002 clinical trial study. As a GAP study partner, Cognivue will join Biogen and other participating strategic partners: Fujirebio; LifeArc; Linus Health; Lucent Diagnostics, a Quanterix brand; RetiSpec; Sunbird Bio; ViewMind Inc.; Ainostics; Cambridge Cognition; iLoF; and Cummulus Neuroscience.
Bio-Hermes-002 is a longitudinal study to investigate and track digital and blood-based biomarkers and their relationship to tau and amyloid PET imaging in older participants who are cognitively normal (CN), have mild cognitive impairment (MCI), or have mild-to-moderate AD dementia over time. The study will build on the findings from Bio-Hermes-001 and the use of biomarkers to streamline future AD diagnostic and assessment processes.
Cognivue’s FDA-cleared digital cognitive assessment technology will be one of the digital biomarkers used in the Bio-Hermes-002 study. The study will utilize the Cognivue Clarity® device, which digitally customizes the testing experience to each test taker’s baseline visual and motor abilities, providing a sensitive, reliable, and standardized approach to testing. The technology captures over 130,000 data points to enable a multi-domain cognitive assessment. Its proven ability to distinguish between cognitively normal individuals, those with MCI, and mild dementia—regardless of amyloid status.1,2 Validated against standard neuropsychological measures,3-8 Cognivue offers an innovative approach to cognitive testing that benefits both research and patient care.
“The work Cognivue did with GAP as part of the Bio-Hermes-001 study was meaningful. Our technology was in good company; it was an honor to be amongst other esteemed digital and plasma biomarkers in a study with a racially diverse cohort. The data from BH1 showed that Cognivue Clarity can reliably characterize amyloid status, even within the cognitively normal group. Our participation in BH2 will allow us to continue to gather data to support Cognivue Clarity’s ability to predict underlying AD pathologies and analyze MRI, neuroinflammation and longitudinal data—further establishing Cognivue’s important role in the timely assessment and diagnosis of dementia and enrichment of clinical trial recruitment,” said Paul W. Estes, president of Cognivue. “We look forward to working with our friends at GAP and the trial sites again.”
“Cognivue was a tremendous partner in the inaugural Bio-Hermes study, and we welcome back their novel technology to help us improve the lives of those impacted by Alzheimer’s disease, in Bio-Hermes-002. An Alzheimer’s diagnosis can start at the primary care provider’s office, and the Cognivue technology can make it easier for primary care physicians to evaluate and treat cognitive impairment,” said John Dwyer, president of the Global Alzheimer’s Platform Foundation.
For more information about the Bio-Hermes-002 study and how to participate, visit https://globalalzplatform.org/.
References:
- Galvin, J.E., Kleiman, M.J., Estes, P.W. et al.Cognivue Clarity characterizes mild cognitive impairment and Alzheimer’s disease in biomarker confirmed cohorts in the Bio-Hermes Study. Sci Rep 14, 24519 (2024). DOI: 1038/s41598-024-75304-5.
- Galvin JE, et al. (2024). Detection of Amyloid Status and Preclinical Alzheimer’s Disease Using Cognivue Clarity, an Adaptive Psychophysics Computerized Cognitive Battery in the Bio-Hermes Study. Poster presented at: the Alzheimer’s Association International Conference (AAIC); July 27-Aug 1; Philadelphia, PA.
- Cahn-Hidalgo D, et al. (2020). Validity, reliability, and psychometric properties of a computerized, cognitive assessment test (Cognivue®). World Journal of Psychiatry, 10(1), 1–11. DOI: 5498/wjp.v10.i1.1.
- Andrefsky J, et al. (2020) Superior Test-Retest Reliability of Cognitive Assessment with Cognivue® vs Slums During an 18-Month Longitudinal Study, Neurol Sci Neurosurg, Volume 2:1. 114. DOI: 47275/2692-093X-114.
- Ma F, et al. (2021) Clinical Validation of Cognivue®– A Computerized Alternative to the Montreal Cognitive Assessment Test. Neurol Sci Neurosurg, Volume 2:2. 116. DOI: 47275/2692-093X-116.
- Galvin JE, et al. Bridging the Assessment Gap: Newly Developed Neuropsychiatric Cognitive Assessments on the Cognivue Platform Show Strong Correlation with Traditional Gold Standard Tests. Poster presented at: the Clinical Trials for Alzheimer’s Disease (CTAD) Annual Conference; October 24-27, 2023; Boston, MA.
- Galvin JE, et al. Cognitive Assessment with Cognivue Clarity®: Psychometric Properties and Normative Ranges in a Diverse Population. J Alzheimers Dis. 2024;100(2):509-523. DOI: 3233/JAD-240331.
- Montgomery B, et al. (2024). Comparing a Comprehensive Neuropsychological Battery Diagnosis to a Diagnosis Given by a Brief Computerized Assessment Tool. Poster presented at: the International Neuropsychological Society Meeting (INS); February 14-17, 2024; New York.
