Oct 30, 2024 | staff reporterSave for later

NEW YORK – The Global Alzheimer’s Platform (GAP) Foundation has launched the Bio-Hermes-002 study, in which it will continue to explore biomarkers that can predict the likelihood that a patient has amyloid and tau accumulations in their brains, signaling a potential Alzheimer’s diagnosis.

The Alzheimer’s research-focused nonprofit announced the launch of the study earlier this week, which follows Bio-Hermes-001. In that first study, the GAP Foundation and its research partners compared results of multiple blood-based biomarker tests to either results from brain PET scans with Eli Lilly’s Amyvid (florbetapir F-18) radiotracer or cerebrospinal fluid (CSF) assays that were sent to a CLIA-certified lab at Quest Diagnostics for analysis. In a recent publication, the study authors reported a strong correlation between results from several blood tests and the presence of beta-amyloid plaque determined by standard testing methods.

Blood-based biomarker tests, if shown to be comparable to traditional Alzheimer’s diagnostics like PET scans and CSF analysis, could be a less expensive and invasive method for determining who has Alzheimer’s and whether patients are eligible to receive drugs that target beta-amyloid and tau.

In Bio-Hermes-002, the GAP foundation is hoping to evaluate the ability of individual or a combination of biomarkers to predict amyloid and tau aggregation. In this second study, like the one before it, the foundation will aim to enroll at least 25 percent of participants from groups traditionally underrepresented in research.

Biogen, which comarkets the anti-amyloid Alzheimer’s drug Leqembi (lecanemab) with Eisai, was a partner on Bio-Hermes-001 and is providing funding for Bio-Hermes-002. The GAP Foundation is also partnering with several organizations that will assess blood-based and digital biomarkers within this new study, including Cognivue, Fujirebio, LifeArc, Linus Health, Quanterix brand Lucent Diagnostics, Retispec, Sunbird Bio, ViewMind, Ainostics, Cambridge Cognition, iLoF, and Cumulus Neuroscience.

“We are pleased to bring together a distinguished consortium of leaders in research and technology to join us in the Bio-Hermes-002 study,” John Dwyer, president of the GAP Foundation, said in a statement. “This study is critical for the eventual development of tests that could be offered in a primary care setting, leveling the diagnostic and treatment playing field for many who for too long have lacked access to both.”

Data from Bio-Hermes-002 study will be stored on the Alzheimer’s Disease Data Initiative’s cloud-based data sharing and analytics environment, called AD Workbench, enabling researchers to share, access, and analyze the data across different platforms. After Bio-Hermes-002 is closed, the GAP Foundation will make the data from the study available to researchers worldwide through the AD Workbench.