ENEA - Agenzia nazionale per le nuove tecnologie, l’energia e lo sviluppo economico sostenibile

11/13/2025 | Press release | Distributed by Public on 11/13/2025 06:56

Health: Alzheimer’s, ENEA patents biomarkers for early diagnosis

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Health: Alzheimer's, ENEA patents biomarkers for early diagnosis

13 November 2025 Last Updated: 13 November 2025

A next-generation, non-invasive approach for the early diagnosis of Alzheimer's disease - aimed at improving disease management and patients' quality of life - has been patented by ENEA's RED Biotechnology Laboratory, within the framework of the National Research Plan 2021-2027. The next step will be to develop a low-cost and non-invasive test.

The research identified new biomarkers in fecal samples capable of providing an early diagnosis and more accurate prognosis, using a multidisciplinary molecular biology approach and a model replicating the disease observed in humans and its staging.

"It is now widely demonstrated that there is a strong relationship between gut microbiota composition and the development of neurodegenerative diseases, including Alzheimer's. In particular, conditions of gut dysbiosis[1] have been associated with an increased risk of developing the disease", explains Roberta Vitali, ENEA researcher and team leader of the project. "Starting from the hypothesis that alterations in the microbiota could translate into molecular changes detectable in fecal samples," she continues, "we proposed feces as a matrix for screening Alzheimer's biomarkers. Our hypothesis was that specific microRNAs[2] and proteins present in feces could serve as disease markers."

The panel of identified molecules has been patented, and a selection of the identified microRNAs and proteins has been validated in fecal samples representing different stages of the disease. The results confirmed that these molecules are modulated in specific phases of the pathology or in correlation with its progression, making them promising biomarkers for diagnosis and prognosis.

"The analysis of these fecal biomarkers in samples obtained from patients will lay the groundwork for developing diagnostic methods that are sustainable and repeatable over time., enabling earlier and more accessible diagnosis, increasing the effectiveness of potential therapies, and reducing costs compared to invasive methods such as cerebrospinal fluid collection. This will make a significant contribution to controlling a disease with major social and healthcare impacts," concludes Vitali.

Alzheimer's disease is the most common form of senile dementia and represents a growing global health emergency. In Italy, it affects about 5% of people over 60, and according to the World Alzheimer Report 2015, more than 46.8 million people worldwide are living with some form of dementia.

Notes

[1]Imbalance in the composition and functioning of the intestinal microbiota, that is, the "bacterial flora" that lives in the intestine

[2]Small fragments of non-coding RNA, usually about 20-22 nucleotides long, that play a crucial role in regulating gene expression

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