These landmark findings and the study behind the metric, “The Cognivue Amyloid Risk Measure (CARM): A Novel Method to Predict the Presence of Amyloid with Cognivue Clarity,” were recently published in the peer-reviewed journal, Neurology and Therapy, and are available at https://link.springer.com/article/10.1007/s40120-025-00741-x.

“Alzheimer’s disease affects nearly seven million people in the U.S.,² yet early detection remains a significant challenge—especially outside expert centers,” said James Galvin, MD, MPH, Chief Scientific Officer at Cognivue. “Cognivue Clarity addresses this critical need by providing a quick, reliable screening to evaluate cognitive function. Now, with the addition of CARM, we can estimate amyloid risk in-office—giving healthcare professionals a powerful, non-invasive tool to inform decisions and next steps.”

By predicting amyloid presence earlier as an initial screening strategy, the CARM can help clinicians identify individuals who may benefit from additional Alzheimer’s biomarker testing—such as Plasma p-tau217—supporting a more accessible and cost-effective screening pathway before pursuing PET imaging.

“At Cognivue, we’re proud to offer a solution that can help identify cognitive changes and amyloid risk earlier,” said Paul Estes, President and CEO of Cognivue. “The CARM metric builds on years of research and empowers patients and their families with actionable insights for timely intervention. Earlier detection means earlier action, which ultimately leads to better outcomes for those affected by Alzheimer’s and other forms of cognitive impairment.”

The Cognivue Amyloid Risk Measure is the latest Cognivue-led research derived from the landmark Bio-Hermes study sponsored by the Global Alzheimer’s Platform Foundation. It marks a significant step forward in advancing early detection of cognitive impairment. It is the third in a growing body of peer-reviewed research validating Cognivue Clarity’s utility in detecting and characterizing cognitive decline.

This new study builds on two previously published studies:

• “Cognivue Clarity characterizes mild cognitive impairment and Alzheimer’s disease in biomarker confirmed cohorts in the Bio-Hermes Study,” published in Scientific Reports, confirmed its ability to reliably differentiate between cognitively normal individuals, those with mild cognitive impairment (MCI), and those with mild dementia—regardless of amyloid status.³
• “Cognivue Clarity characterizes amyloid status and preclinical Alzheimer’s disease in biomarker confirmed cohorts in the Bio-Hermes Study,” published in the Journal of Alzheimer’s Disease, demonstrated Cognivue Clarity’s ability to screen for cognitive impairment, identify amyloid-positive individuals, and detect signs of preclinical Alzheimer’s disease.⁴

“Together, these studies offer more than scientific insight—they represent a growing body of evidence supporting Cognivue Clarity as a practical, scalable solution for cognitive assessment,” said Heather Harris, Senior Vice President of Scientific Affairs for Cognivue. “Integrated into routine care, Cognivue Clarity and CARM enable the TIER approach—identifying candidates for Treatment, Inclusion in clinical trials, Exploratory testing, and Routine cognitive screening. This streamlined assessment supports faster, more informed decisions while delivering value across the broader healthcare system.”