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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda Ospedaliero Universitaria Careggi Firenze
RECRUITING
Florence
IRCCS Don Gnocchi, Fondazione Don Gnocchi
RECRUITING
Florence
IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
RECRUITING
Milan
Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus
RECRUITING
Parma
Contact Information
Primary
Pietro Arcuri, MD
parcuri@dongnocchi.it
+390240308833
Backup
Alice Gualerzi, PhD
agualerzi@dongnocchi.it
+390240308533
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 242
Treatments
Alzheimer's Disease (AD)
70 subjects.
Parkinson's Disease (PD)
70 subjects
Atypical Parkinsonism (AtPD)
42 subjects comprehending people diagnosed with Multiple System Atrophy (MSA), Progressive Sopranuclear Palsy (PSP) and Corticobasal Degeneration (CBD).
Prodromal Phase of Parkinson's Disease
30 subjects
Mild Cognitive Impairment (MCI)
30 subjects
Sponsors
Collaborators: Fondazione Regionale per la Ricerca Biomedica, Azienda Ospedaliero-Universitaria Careggi, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov