About this trial
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.
Eligibility criteria
Qualifiers
AD: standard criteria for dementia due to AD with AD neurochemical demonstration.
PD: MDS Criteria; modified Hoehn&Yahr stages; stable pharmacological treatment (last 4 weeks).
AtP: current consensus diagnostic criteria for progressive supranuclear palsy; corticobasal degeneration and multiple system atrophy.
prodromic PD: according to diagnostic criteria by Berg;
Disqualifiers
For all the experimental groups considered, subjects with concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic diseases, oncological or infectious diseases will be excluded.
Patients not able to provide written informed consent autonomously will be excluded.
For PD patients: Vascular, familiar and drug- induced parkinsonism, other known or suspected causes (metabolic, brain tumor etc) or any suggestive features of AtP; dementia with MoCA Test Correct Score<15
Trial design
Treatments tested in this trial
- Saliva collection, longitudinal
Treatment groups
Sponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Fondazione Regionale per la Ricerca Biomedica
Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator