Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06869135

Saliva and Extracellular Vesicles for Neurodegenerative Diseases

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

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.

Official title: Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

242

Start Date

2025-01-24

Completion Date

2027-12-15

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

OTHER

Saliva collection, longitudinal

1 ml of saliva will be collected with Salivette swabs. Subjects will undergo assessments and saliva sampling at enrollment time (T0) and one year after (T12).

Locations (5)

IRCCS Don Gnocchi, Fondazione Don Gnocchi

Florence, FI, 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

Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus

Parma, Italy