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Saliva and Extracellular Vesicles for Neurodegenerative Diseases

NCT06869135 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

  • Neurodegenerative Diseases
  • Parkinson Disease
  • Alzheimer Disease
  • Parkinsonism
  • Mild Cognitive Impairment (MCI)
  • Prodromal Parkinson's Disease

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).

Sponsors & Collaborators

  • Fondazione Regionale per la Ricerca Biomedica

    collaborator OTHER

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Careggi

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Alice Gualerzi, PhD · IRCCS Fondazione Don Gnocchi

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-24
Primary Completion
2027-03-31
Completion
2027-12-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869135 on ClinicalTrials.gov