International study tests whether dried blood spot analysis can replace expensive brain scans and invasive procedures for detecting disease markers.
An international research collaboration is testing whether a simple finger-prick blood test can diagnose Alzheimer’s disease by analyzing three key protein biomarkers, potentially offering a more accessible alternative to current diagnostic methods that rely on expensive brain scans and lumbar punctures.
The Bio-Hermes-002 study, led by the Global Alzheimer’s Platform Foundation in partnership with LifeArc and the UK Dementia Research Institute, has enrolled 883 of its target 1000 participants across 25 sites in the UK, US, and Canada. More than 360 participants have completed testing to date.
The finger-prick test uses a plasma separation card that does not require refrigeration and can be stored and shipped to laboratories at ambient temperature, making it significantly more cost-effective and accessible than current diagnostic approaches.
Researchers are analyzing blood samples for three protein biomarkers associated with Alzheimer’s disease: phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light polypeptide (NfL). Results will be compared against current gold standard diagnostic methods including PET scans and MRI imaging, as well as other experimental tests such as speech analysis, retinal scans, and cognitive assessments.
“Over the last five years, there has been substantial progress in identifying blood-based biomarkers to identify people at high risk of developing Alzheimer’s disease before their symptoms present,” says Dr Giovanna Lalli, director of strategy and operations at LifeArc, in a release. “Developing cheaper, scalable, and more accessible tests is vital in the battle against this devastating condition.”
Addressing Diagnostic Accessibility Challenges
Current Alzheimer’s diagnosis relies on expensive brain imaging and invasive spinal taps that can be costly, time-consuming, and inaccessible in areas with limited healthcare infrastructure. The dried blood spot approach aims to address these barriers while potentially enabling earlier intervention when treatments may be more effective.
The study population includes cognitively normal individuals, those with mild cognitive impairment, and patients with mild to moderate Alzheimer’s disease. Notably, researchers expect at least 25% of volunteers to come from underrepresented ethnic groups, addressing a significant gap in clinical trial participation.
“This study is unique in its size and scope, with 30% of volunteers being recruited from under-represented groups,” says Prof Henrik Zetterberg, lead of the Biomarker Factory at the UK Dementia Research Institute, in a release. “If successful, being able to diagnose Alzheimer’s with a minimally invasive, cost-effective method will revolutionize diagnostics in this area.”
The inclusion of diverse populations is particularly important given that Black and Hispanic individuals are twice as likely to develop Alzheimer’s disease compared to white individuals, yet their participation in clinical trials often remains below 20%.
Clinical Implementation Timeline
John Dwyer, president of GAP, says the dried blood spot test “has the potential to revolutionize diagnosis by making a timely diagnosis accessible to more people, including those who have limited access to specialized healthcare,” in a release.
The trial is expected to be completed in 2028. Additional evidence will be needed before blood-based testing can be implemented in healthcare systems like the NHS, but the study aims to validate the finger-prick approach across a large-scale, internationally diverse population.
Dr Emer MacSweeney, CEO and medical director of Re:Cognition Health, emphasizes the importance of early detection capabilities. “As disease-modifying treatments emerge, these new AD treatments are most effective when given, as early as possible, when symptoms are still very mild,” she says in a release.
The research builds on recent advances in blood-based biomarker development for neurodegenerative diseases, with the potential to extend diagnostic improvements to other neurological conditions beyond Alzheimer’s disease.
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