Saliva and Extracellular Vesicles for Neurodegenerative Diseases

NCT06869135 | Recruiting

• 3 other identifiers: FDG_MINERVACET 97/24FDG 17_17/09/2024
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Neurodegenerative Diseases; Parkinson Disease; Alzheimer Disease; Parkinsonism; Mild Cognitive Impairment (MCI); Prodromal Parkinson's Disease

Keywords

Saliva; Raman Spectroscopy; Extracellular Vesicles; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Salivary Raman fingerprint of AD, PD, AtPD, prodromal PD and MCI

  Differences in the Raman spectra of saliva of patients with AD, PD, AtPD, prodromal PD and MCI in the spectral range 400-1800 cm-1

  From the enrollment to the follow up evaluation and second sample collection at 12 months

Secondary Outcomes (6)

• Raman fingerprint of salivary EV of AD, PD, AtPD, prodromal PD and MCI

  From the enrollment to the follow up evaluation and second sample collection at 12 months

• Salivary NDD biomarkers

  From enrollment to follow up evaluation and second sample collection at 12 months

• Salivary Raman fingerprint of patients after 1 year

  From enrollment to follow up and second sample collection at 12 months

• Salivary EV Raman fingerprint of patients after 1 year

  From enrollment to follow up and second sample collection at 12 months

• Correlation of Raman data with clinical assessment

  From enrollment to follow up at 12 months

Study Arms (5)

Alzheimer's Disease (AD)

70 subjects.

Other: Saliva collection, longitudinal

Parkinson's Disease (PD)

70 subjects

Other: Saliva collection, longitudinal

Atypical Parkinsonism (AtPD)

42 subjects comprehending people diagnosed with Multiple System Atrophy (MSA), Progressive Sopranuclear Palsy (PSP) and Corticobasal Degeneration (CBD).

Other: Saliva collection, longitudinal

Prodromal Phase of Parkinson's Disease

30 subjects

Other: Saliva collection, longitudinal

Mild Cognitive Impairment (MCI)

30 subjects

Other: Saliva collection, longitudinal

Interventions

Saliva collection, longitudinal OTHER

1 ml of saliva will be collected with Salivette swabs. Subjects will undergo assessments and saliva sampling at enrollment time (T0) and one year after (T12).

Alzheimer's Disease (AD); Atypical Parkinsonism (AtPD); Mild Cognitive Impairment (MCI); Parkinson's Disease (PD); Prodromal Phase of Parkinson's Disease

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment will take place at Diagnostic and Rehabilitation Center for Parkinson's Disease and Parkinsonism (DiaRiaPARK) of the U.O. of Rehabilitative Neurology of IRCCS S. Maria Nascente (MILAN) of Fondazione Don Carlo Gnocchi and at PROMISE@LAB of IRCCS Don Gnocchi (FLORENCE) of Fondazione Don Gnocchi (FDG). After emedation of the trial protocol and approval by the Local Ethical Committees, recruitment will take place also at Centro S. Maria ai Servi (PARMA), AOU Careggi (FLORENCE) and IRCCS Istituto Neurologico Carlo Besta (MILAN).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Regionale per la Ricerca Biomedica: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (5)

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, 20148, Italy

RECRUITING

IRCCS Istituto Neurologico "Carlo Besta"

Milan, Italy

RECRUITING

Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus

Parma, Italy

RECRUITING

Related Publications (2)

• Carlomagno C, Bertazioli D, Gualerzi A, Picciolini S, Andrico M, Roda F, Meloni M, Banfi PI, Verde F, Ticozzi N, Silani V, Messina E, Bedoni M. Identification of the Raman Salivary Fingerprint of Parkinson's Disease Through the Spectroscopic- Computational Combinatory Approach. Front Neurosci. 2021 Oct 26;15:704963. doi: 10.3389/fnins.2021.704963. eCollection 2021.

  PMID: 34764849 BACKGROUND

• Mangolini V, Gualerzi A, Picciolini S, Roda F, Del Prete A, Forleo L, Rossetto RA, Bedoni M. Biochemical Characterization of Human Salivary Extracellular Vesicles as a Valuable Source of Biomarkers. Biology (Basel). 2023 Jan 31;12(2):227. doi: 10.3390/biology12020227.

  PMID: 36829504 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva containing DNA. DNA will not be analysed separatly.

MeSH Terms

Conditions

Neurodegenerative Diseases; Parkinson Disease; Alzheimer Disease; Parkinsonian Disorders; Cognitive Dysfunction; Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice Gualerzi, PhD

  IRCCS Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Arcuri, MD

CONTACT

+390240308833; parcuri@dongnocchi.it

Alice Gualerzi, PhD

CONTACT

+390240308533; agualerzi@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)