Actively Recruiting
Saliva and Extracellular Vesicles for Neurodegenerative Diseases
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-08-07
242
Participants Needed
5
Research Sites
150 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
F
Fondazione Regionale per la Ricerca Biomedica
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Saliva and Extracellular Vesicles for Neurodegenerative Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease based on standard criteria with neurochemical confirmation
- Diagnosis of Parkinson's disease according to MDS criteria with stable treatment for at least 4 weeks
- Diagnosis of atypical parkinsonism based on current consensus criteria
- Diagnosis of prodromal Parkinson's disease according to Berg's diagnostic criteria
- Diagnosis of mild cognitive impairment according to Dubois and Albert's criteria
You will not qualify if you...
- Presence of chronic or inflammatory diseases of the oral cavity, other systemic diseases, cancer, or infections
- Inability to provide written informed consent independently
- For Parkinson's disease patients: vascular, familial, or drug-induced parkinsonism, other known or suspected causes such as metabolic conditions or brain tumors, or signs suggestive of atypical parkinsonism
- Dementia with MoCA test corrected score less than 15
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
IRCCS Don Gnocchi, Fondazione Don Gnocchi
Florence, FI, Italy
Actively Recruiting
2
Azienda Ospedaliero Universitaria Careggi Firenze
Florence, Italy
Actively Recruiting
3
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy, 20148
Actively Recruiting
4
IRCCS Istituto Neurologico "Carlo Besta"
Milan, Italy
Actively Recruiting
5
Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus
Parma, Italy
Actively Recruiting
Research Team
P
Pietro Arcuri, MD
CONTACT
A
Alice Gualerzi, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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