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NCT06869135Recruiting

Saliva and Extracellular Vesicles for Neurodegenerative Diseases

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
242 (estimated)
First submitted
5 Mar 2025
Start date
24 Jan 2025
Primary completion date
Mar 2027
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
NCT number
NCT06869135

What you commit to

  • Study type: Observational
  • Planned participants: 242
  • From 24 Jan 2025 to the primary completion date, Mar 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

Other

  • Patients not able to provide written informed consent autonomously will be excluded.

Who the study is looking for

  • 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.

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero Universitaria Careggi Firenze
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FlorenceItalyRecruiting
IRCCS Don Gnocchi, Fondazione Don Gnocchi
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FlorenceItalyRecruiting
IRCCS Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
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MilanItalyRecruiting
Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus
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ParmaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.