Insights from the Bio-Hermes Trial A New Perspective on Alzheimer’s Research
Alzheimer’s disease (AD) presents a significant challenge, not only for those diagnosed but also for their families and healthcare providers. As the global population ages, the urgency for effective diagnostic tools and treatment strategies intensifies. The Bio Hermes study, sponsored by the Global Alzheimer’s Platform Foundation (GAP) and supported by IXICO as imaging partner, offers valuable insights into emerging possibilities for efficient and reliant determination of a participant’s amyloid status, a key part of diagnostic and trial recruitment criteria.
This article delves into how data from the Bio-Hermes study enhances our understanding of blood-based biomarkers (BBMs) for p-tau217, as a complement to amyloid positron emission tomography (PET), a gold-standard imaging technique for the measurement of amyloid pathology. By examining the interplay between imaging and BBMs, we highlight how BBMs offer a more accessible, cost-effective, and less invasive alternative where appropriate, acknowledging the need for a gold-standard assessment from PET in certain cases.
The Bio-Hermes Study
This study in over 1000 community-based participants from throughout the US compared the results of blood and digital biomarkers with brain amyloid PET scans or cerebrospinal fluid assays. The study revealed a strong correlation between p-tau217 and the presence of amyloid plaques in the brain, a diagnostic hallmark of Alzheimer’s disease (AD), with several blood-based biomarkers (BBM’s). This relationship was demonstrated across the entire study population including the 24% of Bio-Hermes participants from African American, latino and other traditionally underrepresented communities, an unprecedented level of diversity. These findings will enhance the field’s ability to provide a more economical, timely, and accurate diagnosis of Alzheimer’s disease and speed enrolment into clinical trials.
Exploring a Two-stage Process for Amyloid Assessment
With its rich dataset from a highly diverse population, the Bio-Hermes study offers a valuable source to enhance our understanding of how BBMs may impact future AD clinical trials. In a two-stage screening process potential trial participants initially undergo a blood-based biomarker test, e.g., measuring plasma amyloid beta (Aβ)40, Aβ42, total tau, phosphorylated tau (p-tau)181, or p-tau217. Those with no clear diagnosis from the BBM test will subsequently undergo an amyloid PET scan. Depending on the screening paradigm, individuals with a positive BBM test outcome may also receive a confirmatory PET measurement. This two-stage screening process reduces screen failure rates associated with invasive and more costly amyloid PET and thereby improves the efficiency of identifying suitable candidates for clinical trials.
A key objective of the Bio-Hermes study is its commitment to inclusivity. Approximately 2,500 participants were pre-screened for possible inclusion in the core study, with 956 receiving an Amyloid PET
Scan, and 924 participants had all the measurements taken required to simulate the proposed two-stage screening process. With a focus on traditionally underrepresented populations, of these 924 participants included here, 104 were Black or African American, 803 White and 16 Asian participants. Moreover, 11% of the included participants identified as Hispanic or Latino. This diversity is essential for ensuring that the findings are applicable across various demographic groups, reflecting the realities of those affected by Alzheimer’s disease.
