Researchers seek to enable low-cost early diagnosis at scale to support population level disease screening.
A new international research study is exploring whether a simple “finger-prick” blood test could help diagnose Alzheimer’s disease years before the onset of symptoms. A joint initiative between medical research non-profit LifeArc, the Global Alzheimer’s Platform Foundation and the UK Dementia Research Institute, the project aims to discover whether a low-cost, minimally invasive test can match the accuracy of current diagnostic tools.
Today’s gold standard for Alzheimer’s diagnosis requires brain imaging such as PET scans or collecting cerebrospinal fluid through lumbar punctures to measure levels of amyloid and tau proteins linked to the disease. While these methods are considered highly accurate, they are expensive, invasive and hard to deliver at scale.
As a result, many people are diagnosed only after symptoms are well established – an issue that has become more significant since the recent regulatory approvals of drugs such as aducanumab and lecanemab, which are intended for people in the earliest stages of the disease. Making such treatments viable on a population level requires practical ways to identify at-risk individuals early and reliably.
In the past year, the US FDA cleared the first blood test to aid in diagnosing Alzheimer’s by detecting amyloid plaques in adults over 55 who have symptoms, and also approved Roche’s blood-based biomarker test to help rule out Alzheimer’s-related amyloid pathology. While these tests require venous blood draws, the finger-prick project aims to go a step further by aiming to dramatically increase ease of use and scalability.
“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,” said LifeArc’s Giovanna Lalli. “Developing cheaper, scalable and more accessible tests is vital in the battle against this devastating condition.”
The new finger-prick study is part of a concerted multinational effort to advance Alzheimer’s diagnosis through blood-based and digital biomarkers. Instead of a traditional blood draw, the researchers are using a plasma separation card that allows a small blood sample to be collected from a finger prick, dried and shipped at room temperature. If successful, the approach could simplify logistics and reduce costs, potentially opening the door to widespread early screening programs.
Scientists will analyze the samples for three proteins associated with Alzheimer’s pathology: phosphorylated tau 217, glial fibrillary acidic protein and neurofilament light. Results will be compared with PET and MRI scans, as well as other emerging diagnostic approaches, including blood tests and measures such as speech analysis, retinal imaging and cognitive assessments.
Enrollment in the study is already nearing completion, with 883 of the planned 1,000 participants having been recruited from sites across the UK, the United States and Canada. The cohort includes “cognitively normal” individuals, people with mild cognitive impairment and patients with mild to moderate Alzheimer’s disease.
According to the organizations leading the initiative, equity and representation are central to the trial’s design. Around a quarter to a third of participants are being recruited from under-represented groups, an intentional effort to address long-standing gaps in Alzheimer’s research.
“This study is unique in its size and scope, with 30% of volunteers being recruited from under-represented groups,” said the UK Dementia Research Institute’s Prof Henrik Zetterberg. “If successful, being able to diagnose Alzheimer’s with a minimally invasive, cost-effective method will revolutionize diagnostics in this area and pave the way for improved diagnosis of all neurodegenerative conditions.”
The trial is expected to run through 2028. If the data support the promise of finger-prick testing for Alzheimer’s, significant work remains before such a test could be integrated into routine care. Further large-scale studies would be needed to confirm accuracy, reliability and clinical usefulness across populations. But for now, the researchers are focused on answering a simple question: can a single drop of blood meaningfully help change the trajectory of one of the world’s most devastating diseases?
