Saliva Test for Early Detection of Brain Diseases
Tests saliva samples over time to help detect Parkinson's and Alzheimer's disease early.
Key facts
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Where
- Florence, Milan, and Parma, ItalySee the 5 sites
- Trial code
- Registry title
- Saliva and Extracellular Vesicles for Neurodegenerative Diseases
- Status
- Recruiting
- People taking part
- 242 people, planned
- Started
- 24 Jan 2025
- Expected to end
- 15 Dec 2027
- Type of study
- Observational, 5 groups
- Treatments tested
- Saliva collection, longitudinal
- Record updated
- 7 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 45 or older with Alzheimer's disease, Parkinson's disease, atypical parkinsonism, early (prodromal) Parkinson's or mild cognitive impairment. Saliva is collected for testing.
- Age
- 45 years or older
- Sex
- All sexes
- Disease stage
- Alzheimer's disease with proof from tests, Parkinson's disease (graded on the modified Hoehn & Yahr stages), atypical parkinsonism (progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy), early Parkinson's, or mild cognitive impairment.
- Earlier treatment
- People with Parkinson's disease must have been on stable drug treatment for the last 4 weeks.
- Biomarker or test result
- People with Alzheimer's disease must have the disease shown by a neurochemical test.
Main reasons for not taking part
- Long-lasting or inflammatory disease of the mouth
- Other body-wide, cancer or infectious diseases
- Cannot give written informed consent alone
- Parkinson's patients with vascular, family-related or drug-caused parkinsonism, or other known causes
- Parkinson's patients with dementia (MoCA score below 15)
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Patients not able to provide written informed consent autonomously will be excluded
Where in Italy
- Azienda Ospedaliero Universitaria Careggi FirenzeFlorence, ItalyContact: Silvia Ramat, MD, PhDTaking people
- IRCCS Don Gnocchi, Fondazione Don GnocchiFlorence, ItalyContact: Francesca Cecchi, MDTaking people
- IRCCS Istituto Neurologico Carlo BestaMilan, ItalyContact: Gemma LombardiTaking people
- IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUSMilan, ItalyContact: Alice Gualerzi, PhDTaking people
- Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi OnlusParma, ItalyContact: Valerio Brambilla, MDTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- Alzheimer's Disease (AD)
70 subjects.
Treatment: Saliva collection, longitudinal
- Parkinson's Disease (PD)
70 subjects
Treatment: Saliva collection, longitudinal
- Atypical Parkinsonism (AtPD)
42 subjects comprehending people diagnosed with Multiple System Atrophy (MSA), Progressive Sopranuclear Palsy (PSP) and Corticobasal Degeneration (CBD).
Treatment: Saliva collection, longitudinal
- Prodromal Phase of Parkinson's Disease
30 subjects
Treatment: Saliva collection, longitudinal
- Mild Cognitive Impairment (MCI)
30 subjects
Treatment: Saliva collection, longitudinal
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling
- Plain-language title
- Saliva Test for Early Detection of Brain DiseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 August 2025