Alzheimer's disease represents one of the major health challenges of our time. In Italy, it is estimated that more than one million people are affected by a form of cognitive impairment of a neurodegenerative nature, most of which can be attributed to Alzheimer's disease. With an increasingly elderly population-more than 23 percent of Italians are over 65-the pressure on the health care system is bound to increase exponentially.
In this context, early diagnosis assumes fundamental strategic value. Recognizing the pathology early makes it possible to activate targeted interventions, slow the progression of symptoms and significantly improve the quality of life of patients and their families. But until now, the most accurate diagnostic methods have often been invasive, expensive or difficult to access outside highly specialized centers.
An important breakthrough comes from plasma markers, and in particular from a recent study published in the prestigious journal Nature Medicine, in which the University of Brescia and ASST Spedali Civili di Brescia, in collaboration with the Universities of Lund, Gothenburg, and Barcelona, were among the protagonists. The study involved more than 1,700 patients with cognitive symptoms from five different European centers, demonstrating that the p-tau217/amyloid marker in plasma, measured by a fully automated test, can identify the presence of Alzheimer's pathology with very high accuracy, exceeding 90 percent in specialist care settings and at 85 percent in general medicine. Reinforcing these results, a study on a larger cohort from Spedali Civili di Brescia and University of Brescia published in Brain compared for the first time the clinical performance of plasma p-tau217 measured by automated technique with semi-automated SIMOA, confirming the correlation between the two methods and the very high diagnostic reliability.
Confirming the validity of this approach, on May 16, 2025, the U.S. Food and Drug Administration (FDA) approved the commercialization of the pTau217/β-Amyloid 1-42 Plasma Ratio test as the first FDA-authorized blood test to support the diagnosis of Alzheimer's disease.
The research projects were carried out by the Neurology Clinic of the University's Department of Experimental Clinical Sciences, within the Continuity of Care and Frailty Department of ASST Spedali Civili of Brescia, under the direction of Prof. Alessandro Padovani. The work, which is translational in nature, was a collaboration between the Neurological Clinic, the Nocivelli Center and the Central Laboratory of ASST Spedali Civili directed by Dr Duilio Brugnoni, with the fundamental contribution of Prof Andrea Pilotto, Dr Quaresima, Dr Tolassi and the entire team of the two participating laboratories.
The development program for the coming years includes a major clinical, methodological and technological advancement, supported by major funding coordinated by the SC. Neurology, part of the PNRR healthcare program for ASST Spedali Civili di Brescia (€3.3 million) and PNRR PRIN and Cascade Call for University of Brescia (€2.2 million). These major development programs aim at technical improvement of plasma assays and their adaptation in different clinical settings, with involvement of wider network of national and international external validation centers. The studies will also include, with support from the Lombardy Region and PNRR University, a fundamental integration of biological markers with other imaging, neurophysiological and digital modalities of cognitive and motor assessment. This will allow in the medium to long term to use the same integrated markers also for a broader study of brain health in the general population.