Affecting millions of people globally, Alzheimer’s disease is a progressive brain disorder that slowly damages memory, thinking, and behavior. In its later stages, it can make simple daily tasks, like eating or recognizing loved ones, nearly impossible. It is the most common type of dementia, a general term for memory loss and cognitive decline. According to the World Health Organization, more than 55 million people worldwide live with dementia, and Alzheimer’s accounts for 60-70% of those cases.
Although the exact cause of Alzheimer’s is not fully understood, it’s linked to the build-up of toxic proteins in the brain, including amyloid plaques and tau tangles, which interfere with normal brain function.
And now, scientists have made a breakthrough in Alzheimer’s detection: a simple blood test that can identify the progressive brain disorder in just minutes. No longer limited to expensive PET scans or invasive spinal taps, this fast and reliable test spots key proteins in the blood (p-Tau217 and beta-amyloid 1-42) that are strong indicators of Alzheimer’s biology.
With FDA approval now in hand, the test offers a far easier, faster path to early diagnosis for adults aged 55 and older who are showing cognitive changes.
What does research say?
Led by Sebastian Palmqvist at Lund University in Sweden, the research team dealt with a prospective study of 1,213 patients seen in both family practices and specialty memory clinics, a serum panel correctly identified Alzheimer’s pathology about 88 to 92 percent of the time.
What did the test entail? The test looked for a specific biomarker in plasma called phosphorylated tau 217, often shortened to p-tau217. It also read the ratio of amyloid beta 42 to amyloid beta 40, two forms of a protein linked to plaques in Alzheimer’s disease. These measurements rise or fall in characteristic ways when Alzheimer’s pathology is present. By combining them, the test gave a single probability score that tracks the biology behind memory loss, not just the symptoms.
What is the blood test?
The test, known as Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, has recently received FDA clearance. It measures the levels of two proteins – phosphorylated tau 217 (p-Tau217) and beta-amyloid 1-42 – in a blood sample. Combining these measurements into a single ratio helps doctors determine whether amyloid plaques, a hallmark of Alzheimer’s disease, are present in the brain.
Why it’s an important stepping stone?
Before this test, diagnosing Alzheimer’s typically relied on PET scans or collecting cerebrospinal fluid through spinal taps – both of them costly, time-consuming, and often limited to specialized centers. The new blood test is less invasive, more affordable, and easier to access.
What about accuracy?
Why does the medical community have high hopes? Because clinical trials of the Lumipulse test have shown high accuracy:
92% of positive blood test results correctly matched the presence of amyloid plaques verified by PET scans or spinal fluid tests.
97% of negative results were confirmed as true negatives.
Such accuracy rates bring it close to traditional methods and make it a trusted option for early detection.
Who is eligible to take it?
The test is FDA-approved for adults aged 55 and older who are showing signs of cognitive decline, such as memory issues or difficulty with thinking. It is not intended for general screening in symptom-free individuals.
How the test works
A primary care physician or specialist orders the test. The patient’s blood is drawn and sent to a laboratory equipped to analyze these biomarkers. Results are typically available within a few days. High scores suggest a high likelihood of Alzheimer’s pathology; low scores indicate a likely absence. A middle-range result may require follow-up with imaging or further testing.
Treatment and planning benefits
Early detection matters more than ever. FDA-approved treatments like Leqembi (lecanemab) and Kisunla (donanemab) are designed to clear amyloid plaques, but they are most effective in the early stages of Alzheimer’s. With the blood test, doctors can identify suitable patients faster, potentially before symptoms worsen.
Why does it matter *so much*
Primary care accuracy in diagnosing Alzheimer’s without biomarker tools hovers around 61%, compared to 73% for specialists. This blood test significantly improves the ability of general practitioners to screen for the disease early, reducing unnecessary specialist referrals and speeding up access to proper treatment.
Furthermore, for people in rural areas or places without access to advanced imaging, this test offers new opportunities. Because it only requires a blood draw, even smaller clinics can offer Alzheimer’s screening, making early diagnosis broader and more equitable.
Limitations and considerations
Despite its accuracy, it’s important to note that the test is not a standalone diagnosis. Doctors must interpret results alongside clinical evaluations, medical history, cognitive testing, and, if needed, imaging or spinal fluid tests. Additionally, insurance coverage remains varied and may not fully cover the test in every region, though FDA approval improves the odds of coverage.
What’s next
This is the first of many blood-based Alzheimer’s tests entering clinical use. Research continues into tests that detect other tau forms or multiple biomarkers to tailor individual care and treatment progression.
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