Using saliva and extracellular vesicles to diagnose neurodegenerative diseases
Official title: Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling
Run by Fondazione Don Carlo Gnocchi ETS · NCT06869135 · Data updated 2026-11-12
This study is testing a new way to diagnose neurodegenerative diseases like Alzheimer's and Parkinson's by analyzing saliva samples to see if it can help identify these conditions earlier and tailor treatments for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 242 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 5 sites (Florence, FI and 4 other locations) |
| Status | Recruiting |
| Started | January 24, 2025 |
| Main results expected | March 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT06869135 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Alzheimer's disease, Parkinson's disease, atypical parkinsonisms, or mild cognitive impairment.
✕Probably not a fit
Patients with chronic inflammatory diseases of the oral cavity or those unable to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to validate a novel and cost-effective method using Raman spectroscopy to diagnose neurodegenerative diseases such as Alzheimer's and Parkinson's disease. By analyzing saliva and salivary extracellular vesicles, the study seeks to identify biochemical markers that can indicate the presence and progression of these diseases. The approach is non-invasive and focuses on profiling patients over time to enhance early diagnosis and personalized treatment strategies. The study will involve collecting saliva samples from participants with various neurodegenerative conditions to assess changes in their biochemical profiles.
Why it matters
Potential benefit: If successful, this method could lead to earlier and more accurate diagnoses of neurodegenerative diseases, improving patient outcomes and quality of life.
How similar studies have gone: Other studies have shown promise in using saliva for biomarker identification in neurodegenerative diseases, but this specific approach using Raman spectroscopy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Patients not able to provide written informed consent autonomously will be excluded. * 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
Where it's running
-
IRCCS Don Gnocchi, Fondazione Don Gnocchi
Florence, Fi, Italy Recruiting -
Azienda Ospedaliero Universitaria Careggi Firenze
Florence, Italy Recruiting -
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy Recruiting -
IRCCS Istituto Neurologico "Carlo Besta"
Milan, Italy Recruiting -
Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus
Parma, Italy Recruiting
Study contacts
- Principal investigator: Alice Gualerzi, PhD — IRCCS Fondazione Don Gnocchi
- Study coordinator: Pietro Arcuri, MD
- Email: parcuri@dongnocchi.it
- Phone: +390240308833
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.