Saliva and Extracellular Vesicles for Neurodegenerative Diseases

Early diagnosis of Neurodegenerative diseases (NDDs) and accurate patient profiling are key goals needed to tailor prompt personalized therapeutic strategies that can significantly impact disease progression and patients' quality of life. The project will validate a novel, cost-effective and quick biophotonic-based method for early and differential diagnosis of NDDs (Parkinson's disease, atypical parkinsonisms, Alzheimer's disease) and for routine clinical monitoring of NDD progression (longitudinal study). Raman spectroscopy (RS) will be applied to biochemically profile saliva and salivaderived Extracellular Vesicles (sEVs) and to identify a spectroscopic biomarker for NDDs. Optimized protocols for RS will be used to concomitantly evaluate saliva and sEVs from people with NDDs and to detect salivary changes in the biochemical profile, with special focus on EV-associated components. The accuracy of the method in discriminating NDDs at different disease stages and during disease progression will be verified. A nanotechnology-based biomolecular characterization of saliva and sEV will clarify the involvement of specific pathological molecules in NDDs progression.

NCT Number	NCT06869135
Lead Sponsor	Fondazione Don Carlo Gnocchi ETS Collaborators: Fondazione Regionale per la Ricerca Biomedica, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Azienda Ospedaliero-Universitaria Careggi
Conditions	Neurodegenerative Diseases, Parkinson Disease, Alzheimer Disease, Parkinsonism, Mild Cognitive Impairment (MCI), Prodromal Parkinson's Disease
Enrollment	242 participants
Start Date	2025-01-24
Primary Completion	2027-03 (estimated)
Study Completion	2027-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-07