The Global Alzheimer’s Platform Foundation (GAP) closed its ground-breaking blood-based and digital biomarker platform study, Bio-Hermes, which is powered to measure more than 36 technologies’ effectiveness across three stages of Alzheimer’s disease, while drawing from all races and ethnic groups affected by the disease.
WASHINGTON, DC (Nov. 15, 2022) — In 18 months, the Global Alzheimer’s Platform Foundation (GAP) recruited more than 1,000 participants to enroll in the first-ever head-to-head study of blood-based and digital Alzheimer’s (AD) biomarkers.
The study, Bio-Hermes, exceeded its recruitment endpoint, enrolling 24 percent of study volunteers from traditionally underrepresented communities — substantially surpassing the diversity of most AD clinical trials, which typically draw three to six percent of participants who are African American or Hispanic/Latino. Bio-Hermes trial participants included 22 percent representation from African American and Hispanic/Latino populations specifically, with 24 percent diversity when including people who are of Asian and Native American descent.
Bio-Hermes compares the performance of dozens of blood tests, digital cognitive tests, retinal exams, and speech analysis to traditional methods of measuring cognition and beta-amyloid positron emission tomography (PET) scans, the gold standard for measuring AD pathology.
The analysis will be enhanced by a full genomic profile and multiple proteomic profiles on each study participant — another first given the depth of the genomic data and diversity of the study.
Today, up to 50 percent of all Alzheimer’s patients in the United States receive an incomplete or inaccurate diagnosis of their cognitive condition. While PET scans are often required to confirm an Alzheimer’s disease diagnosis, PET images cost thousands of dollars and are generally only available in large medical institutions. According to a recent report, disparities in access to PET imaging in the U.S. disproportionately impact people who are traditionally underrepresented.
“These biomarker technologies are expected to allow broader access to the tools needed for doctors to provide patients with better, more timely insights into their cognitive health,” said GAP President John Dwyer.
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.
“From the first day that we began this study, we knew the field needed to accelerate the validation of blood-based and digital tests that would change how Alzheimer’s disease is assessed and how an individual may learn about their risk for the disease. Bio-Hermes won’t just change Alzheimer’s research and diagnostics. We now have the potential to save and change lives,” Dwyer added.
As a privately funded, landmark study, Bio-Hermes involved collaboration with a host of leading biotech, pharma and nonprofit partners, including Gates Ventures, as well as more than a dozen clinical research sites, which are part of the global GAP-Net research network. A key to the enrollment success is the brave and committed participants who volunteered their time and energy to help advance this important research.
The collaborative nature of the project allows GAP to make the Bio-Hermes data set available to the worldwide Alzheimer’s research community as a public service, with the goal of accelerating Alzheimer’s biomarker research for everyone, including racially and ethnically diverse groups of people.
“Representation in clinical trials is critical to ensure that biomarkers and therapeutics will be effective for everyone living with Alzheimer’s disease,” said Niranjan Bose, the Managing Director of Health and Life Sciences at Gates Ventures. “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.”
“Bio-Hermes is catalyzing the development of Alzheimer’s tests that can eventually be offered by any primary care practice,” Dwyer said. “This is a big win for patients and overburdened health systems, and it has everything to do with advancing health equity for the millions of people living with this disease.”
For more information about the Bio-Hermes study, visit https://globalalzplatform.org/biohermesstudy/.
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About the Global Alzheimer’s Platform Foundation (GAP)
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.