Strategic collaborations are key to improving the pace and access to research.
Undiagnosed and Overlooked
Everyone knows someone impacted by Alzheimer’s disease, as it affects an estimated 55 million people worldwide. What is often overlooked is the shocking number of people who remain undiagnosed due to fear of going to a doctor, lack of access to healthcare or unprecedented wait times to see a specialist. That should concern everyone.
There’s an urgent need for early detection of Alzheimer’s disease to expand treatment and care options. How can we make this happen faster? Innovative collaborations are one way to accelerate clinical research, and the partnership between us, IXICO and the Global Alzheimer’s Platform Foundation® (GAP) can shine a light on the need for more.
A Bold Step Forward: The Launch of Bio-Hermes-001
With the approval of disease-modifying therapies on the horizon, at GAP, we recognized that both the healthcare system and the clinical-trials framework must become more sophisticated to provide better assessments and diagnoses with higher reliability. To address these challenges, we took a bold step forward by launching the Bio-Hermes-001 study in 2021.
The Power of Collaboration
This study was built on collaboration that brought together leading biopharma, technology, and nonprofit partners, along with seventeen GAP-Net clinical research sites around the United States. With over 1,000 community-based participants throughout the US, the study compared the results of blood and digital biomarkers with brain amyloid PET scans and/or cerebrospinal fluid assays.
When the initial results from Bio-Hermes-001 were released, they demonstrated a strong correlation between several blood tests, particularly p-tau 217, with the presence of amyloid plaques in the brain, a diagnostic hallmark of Alzheimer’s disease (AD). This correlation was demonstrated across the entire study population including the unprecedented 24 percent of Bio-Hermes-001 participants from African American, Latino, and other traditionally understudied and underserved communities.
These findings enhance the field’s ability to provide a more economical, timely, and accurate diagnosis of Alzheimer’s disease for everyone, while also accelerating enrollment into clinical trials.
Innovative Diagnostic Tools: From Bio-Hermes-001 to FDA Clearance
In May of 2025, the?FDA gave clearance for the first blood test to diagnose Alzheimer’s disease, Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) which represents the first blood-based test available to physicians and their patients for early detection of amyloid plaques associated with Alzheimer’s disease. This new test presents a faster, less invasive, and more accessible method for diagnosis, in contrast to expensive PET scans or invasive collection of cerebrospinal fluid.
Bio-Hermes-001,?played a principal role in the dataset used to support Fujirebio’s FDA application for clearance of the first groundbreaking blood based IVD available for the diagnosis of Alzheimer’s Disease. As Bio-Hermes’ imaging partner, at IXICO, we led the standardization, collection and expert analysis of PET data which served as the gold standard assessment of amyloid pathology in Fujirebio’s FDA filing.
Bio-Hermes-002 and the Future of Alzheimer’s Diagnosis
Wasting no time, when Bio-Hermes-002 was launched, our collaboration continued. GAP and IXICO recently announced that IXICO is again serving as an imaging partner and collaborator. The Bio-Hermes-002 study is collecting data on how each biomarker in the study, alone or in combination of biomarkers, cannot only diagnose but also predict the accumulation of amyloid and tau in the brain – distinctive characteristics of Alzheimer’s disease.
For Bio-Hermes-002, IXICO will provide a combination of financial investment and analysis services building upon findings from Bio-Hermes-001. Working with all partners engaged in Bio-Hermes-002, IXICO’s unique AI-driven platform and expertise will assist with the neuroimaging analysis of the Bio-Hermes-002 study data.
Furthermore, at GAP and IXICO, we are collaborating to advance early detection of vascular pathology and exploring characteristics of Vascular Dementia (VaD). VaD is the second most common dementia type, yet under-recognized in AD trials—especially among people from understudied populations who bear higher vascular risk and may show non-amyloid cognitive decline.
Through mapping vascular progression in the Bio-Hermes-002 Dataset, we are building a continuum framework to chart progression from normal brain health, early Small Vessel Disease (SVD) changes, and clinical VaD.
The Impact of Strategic Collaborations
Our partnership represents a critical step toward advancing Alzheimer’s research through an innovative and strategic collaboration. As our work together progresses, the insights gained from these biomarkers and neuroimaging analyses will not only deepen our understanding of Alzheimer’s disease but also bring us closer to more accurate diagnostics and predictive tools.
By combining resources across organizations, studies like Bio-Hermes-001 and Bio-Hermes-002 could help pave the way for more personalized, effective treatments in the fight against Alzheimer’s. With each new phase, the research community moves closer to transforming the future of Alzheimer’s care, offering hope to millions affected by this disease.
This blog was authored in partnership with IXICO
On Thursday, October 9, 2025, join us for “Advancing AD Clinical Trials Through Blood-Based Biomarkers & Amyloid PET Imaging,” a webinar on how our collaboration with partners IXICO, and Fujirebio are helping to accelerate progress in Alzheimer’s research. Register for free here: https://events.zoom.us/ev/Apl2Ku3vynp3S204Cl4-zFhH38nKDl7mPFGvdUlaeYafFZ5ezpX_~AswrgQiGyMlMhcmZ2v67c0L0AOLjRu10v8xW5XbTsrUEnXxpBzA2jFFqmg