Clinical trial Recruiting at 5 sites Observational Ages 45 and up

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.

More Alzheimer Disease trials

Quick facts

Study typeObservational
Ages45 Years and up
SexAll
Enrollment242 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations5 sites (Florence, FI and 4 other locations)
StatusRecruiting
StartedJanuary 24, 2025
Main results expectedMarch 2027
Study endsDecember 15, 2027
Registry record updatedAugust 7, 2025
Trial IDNCT06869135 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.