Landmark Study Investigating Novel Alzheimer’s Biomarkers Advances to Data Analysis Stage

WASHINGTON, DC, June 14, 2023 (GLOBE NEWSWIRE) — Up to 50 percent of people in the U.S. with Alzheimer’s receive an imprecise or inaccurate diagnosis of their cognitive condition. The tools typically used to detect the disease, like a PET scan, can cost thousands of dollars and are generally only available in places with large medical institutions. And African Americans are 35 percent less likely to be diagnosed than their White counterparts.

That is unacceptable. 

The Bio-Hermes digital and blood-based biomarker study for Alzheimer’s disease will change how Alzheimer’s disease is assessed and how it is diagnosed and how people may learn about their risk for the disease. Bio-Hermes won’t just change Alzheimer’s research and diagnostics. It has the potential to save and change lives.   

That’s why today, Global Alzheimer’s Platform Foundation® (GAP) President John Dwyer announced the next stage in its Bio-Hermes digital and blood-based biomarker study for Alzheimer’s disease. The study closed in November 2022 with an unprecedented 24 percent level of participation from traditionally underrepresented communities.

“Millions of Americans seek an assessment and diagnosis of their cognitive condition out of fear that they may have dementia. So many of these visits are imprecise or just wrong. Now that the FDA is approving disease-modifying therapies for Alzheimer’s, the demand for testing will greatly increase. The biomarkers being analyzed in Bio-Hermes will catalyze better clinical diagnosis and improve clinical trials. People living with Alzheimer’s disease know all too well the disease doesn’t wait,” Dwyer said. “That’s why we won’t wait, and that drives the urgency behind our work on the Bio-Hermes study. Health systems and patients deserve a better process.”

GAP recently completed its first database lock of the largest collection of digital cognitive tests and blood-based biomarkers for the analysis of Alzheimer’s disease. Now a consortium of study partners including Eli Lilly, Abbvie, Biogen and Merck — as well as Gates Ventures, the Alzheimer’s Drug Discovery Fund and nearly two dozen other biotech companies are analyzing the data and preparing to publish the results. 

Bio-Hermes drew biomarker data from people who are cognitively healthy, those with Mild Cognitive Impairment (MCI), and those with mild Alzheimer’s disease (mAD). 

It also includes a full genomic, proteomic, and PET image profile of each participant. Given the extraordinary participant diversity in the trial population, the Bio-Hermes data set provides an unprecedented opportunity to identify the best solutions for diagnosing Alzheimer’s for everyone, especially the African American and Hispanic/Latino communities that are disproportionally at risk for the disease.

As part of the study, GAP is opening access to these samples to outside researchers and drug developers who can leverage them for independent research projects. In total, the Bio-Hermes samples make up a collection of 80,000 IRB-approved biospecimens that are clinically annotated and biomarker-validated.

Bio-Hermes has the potential to transform disease diagnosis. 

At the time of the study close, Niranjan Bose, managing director of Health and Life Sciences at Gates Ventures, said, “Bio-Hermes’ prioritization of diversity in the study protocols will have tremendous impact nationwide. The data from the study will accelerate the search for simpler diagnostic tests and advance equity in Alzheimer’s research, treatment, and care.”

Dr. Jeffrey Cummings, research professor and director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, said, “Biomarkers are critical to Alzheimer’s disease diagnosis and treatment development. The Bio-Hermes study conducted by the Global Alzheimer’s Platform Foundation will provide remarkable data to support Alzheimer’s disease research and clinical care.” He added, “The study takes us the next step toward our goal of successfully preventing and treating Alzheimer’s disease.”

“From the first day we began this study, we knew we needed to accelerate the validation of blood-based and digital tests. We knew that would change how Alzheimer’s disease is assessed and how people may learn about their risk for the disease. Bio-Hermes won’t just change Alzheimer’s research and diagnostics. It has the potential to save and change lives,” Dwyer said.

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About the Bio-Hermes study:

In 18 months, GAP and its network of clinical research sites throughout the U.S. (GAP-Net) enrolled more than 1,000 volunteers in Bio-Hermes, the first-ever comparison study of blood-based biomarkers and digital Alzheimer’s test technologies. Bio-Hermes compared the performance of dozens of blood tests, digital cognitive tests, retinal exams, and speech analysis to traditional methods of measuring cognition and PET images. The Bio-Hermes data set is expected to inform future clinical practice and clinical trial designs just in time to assist with the surge expected by the pending approval of one or more new therapies to treat Alzheimer’s disease.

About the Global Alzheimer’s Platform (GAP) Foundation:

The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical research, as well as lowering the cost and duration of clinical trials to ensure that no one is left behind. As part of its mission, GAP supports more than 100 clinical research sites worldwide through study start-up and recruitment activities, promoting diversity in research studies, and giving attention to the citizen scientists who make research possible.