Using saliva and extracellular vesicles to diagnose neurodegenerative diseases
Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling
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 |
|---|---|
| Enrollment | 242 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 5 sites (Florence, FI and 4 other locations) |
| Trial ID | NCT06869135 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease, Parkinson's disease, atypical parkinsonisms, or mild cognitive impairment.
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.
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 performed: Other studies have shown promise in using saliva for biomarker identification in neurodegenerative diseases, but this specific approach using Raman spectroscopy is relatively novel.
Eligibility criteria
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 this trial is running
Florence, FI and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.