RecruitingNCT06869135

Saliva and Extracellular Vesicles for Neurodegenerative Diseases

Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

242 participants

Start Date

Jan 24, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether proteins found in saliva and tiny particles released by cells (called extracellular vesicles) can be used as early markers for brain diseases like Alzheimer's disease, Parkinson's disease, and related conditions. **You may be eligible if...** - You have a diagnosis of Alzheimer's disease, Parkinson's disease, a related movement disorder (such as PSP, corticobasal degeneration, or MSA), mild cognitive impairment (MCI), or early Parkinson's symptoms - You are able to provide written consent on your own - Your condition meets the relevant diagnostic criteria for your specific disease **You may NOT be eligible if...** - You have chronic inflammatory or infectious diseases in your mouth - You have another serious illness, including cancer or active infection - You cannot provide informed consent independently - (For Parkinson's patients) You have another suspected cause of your symptoms, such as medication side effects or brain tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSaliva collection, longitudinal

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).