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Saliva and Extracellular Vesicles for Neurodegenerative Diseases

Recruitingn/aAges 45 Years - anyAllFondazione Don Carlo Gnocchi ETS
NCT06869135 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Saliva collection, longitudinal
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Where

5 sites
IRCCS Don Gnocchi, Fondazione Don Gnocchi
Florence, Italy
Azienda Ospedaliero Universitaria Careggi Firenze
Florence, Italy
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy
IRCCS Istituto Neurologico "Carlo Besta"
Milan, Italy
Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus
Parma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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