Saliva and Extracellular Vesicles for Neurodegenerative Diseases
Recruiting · NCT06869135 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Don Carlo Gnocchi ETS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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;
- MCI: according to diagnostic criteria by Dubois and Albert.
Exclusion criteria
- 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
Where it is running
10 locations listed.
- Azienda Ospedaliero Universitaria Careggi Firenze - Florence, Italy
- Azienda Ospedaliero Universitaria Careggi Firenze - Florence, Italy
- IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS - Milan, Italy
- IRCCS Istituto Neurologico "Carlo Besta" - Milan, Italy
- IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS - Milan, Italy
- IRCCS Istituto Neurologico "Carlo Besta" - Milan, Italy
- Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus - Parma, Italy
- Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus - Parma, Italy
- IRCCS Don Gnocchi, Fondazione Don Gnocchi - Florence, FI, Italy
- IRCCS Don Gnocchi, Fondazione Don Gnocchi - Florence, FI, Italy