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3 June, 2025The United States Food and Drug Administration (FDA) advances towards less invasive methods that would allow early detection of the first signs of neurological deterioration, opening up new possibilities for prevention and early treatment
On May 16, the United States Food and Drug Administration (FDA) approved the first blood test to diagnose Alzheimer's disease in people with memory problems. The test, called Lumipulse G, represents a milestone in neurological medicine, since It allows the biological signs of the disease to be detected early, in an accessible and minimally invasive manner.
A diagnosis more accessible than ever
Until now, identifying Alzheimer's required complex tests such as positron emission tomography (PET), a costly, time-consuming technique that involves radiation exposure. Another alternative was a lumbar puncture, an invasive procedure used to obtain cerebrospinal fluid.
With Lumipulse G, everything changes: a blood sample is enoughThis makes it a fast, safe, and easily applicable tool, even in healthcare centers without specialized equipment. Furthermore, it offers high diagnostic accuracy, opening up new possibilities for early detection.
How Does It Work?
This test It measures two key proteins that are altered in the brains of people with Alzheimer's: p-Tau217, a modified form of the tau protein associated with neuronal damage; and Aβ42, a variant of the amyloid beta protein that forms plaques in brain tissue.
The relationship between these two proteins, known as the p-Tau217/Aβ42 ratio, is the best marker available for detect the early presence of amyloid plaques in the brain, a hallmark of Alzheimer's.
Although p-Tau217 is directly linked to the tau protein, it also appears to very accurately reflect the accumulation of amyloid plaques in the brain. In other words, it captures the entire neurodegenerative process.
This biomarker was identified by a team of Swedish scientists in 2020 and has shown a 92% accuracy to detect Alzheimer's in its very early stages, even before symptoms appear.
Prevent, not just treat
We are facing a progressive and silent disease: the accumulation of beta-amyloid plaques can begin more than 20 years before the first memory problems appear. During all this time, the brain may be damaged without any visible signs. Tau protein accumulates later, in stages closer to cognitive decline.
The most interesting aspect of p-Tau217/Aβ42 is that it not only detects the disease early, but is also a dynamic marker: its levels can vary in response to treatments that reduce amyloid plaques or even with regular exercise. This expands its usefulness, since in addition to facilitating diagnosis and prediction, it allows us to assess whether the interventions are having an effect.
We are at the beginning of a new era: personalized Alzheimer's prevention.
For whom is this test indicated?
For now, the Lumipulse G blood test is not intended to be applied to the entire population.The test is intended for patients who present to a specialized care center with signs and symptoms of cognitive impairment. The results should be interpreted in conjunction with the patient's other clinical information.
It is mainly recommended for people over 55 years of age who have mild cognitive decline or memory loss, a family history of Alzheimer's, or genetic risk factors, like the APOE4 allele.
In these cases, testing can be key for making early clinical decisions. However, it should be a personal and voluntary choice: not everyone wants to know their future risk or confirm a possible diagnosis ahead of time.
Still, Alzheimer's represents one of the greatest fears associated with aging for many people. And if there is a way to prevent or slow its onset, this breakthrough could become one of the greatest scientific advances of our time.
Individualized risk profiles
Ultimately, The true potential of the test does not end with the diagnosis.By combining biomarker data with clinical history, lifestyle, and artificial intelligence tools, it will be possible to create individualized risk profiles.
Furthermore, they are developing new drugs that could be used in people who do not yet present clinical symptoms, but who already show early signs in their biomarkers. The objective is clear: intervene before the damage becomes irreversible.
Until now, medicine has been slow to address Alzheimer's. Diagnosis occurred when significant impairment already existed, and available treatments had limited impact. Measuring the p-Tau217/Aβ42 ratio allows us to change that narrative.
We are closer than ever to achieving primary prevention of Alzheimer's, something that until recently seemed unattainable. This marker could become what cholesterol has been for cardiovascular disease: an early warning signal that allows for timely action.
Hopefully this test will soon be available in Europe and other countries as well. Because In the battle against Alzheimer's, every step forward counts.
Source: The Conversation




