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Saliva and Extracellular Vesicles for Parkinson's Disease

NCT05320250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2025-01-13

No results posted yet for this study

Summary

Rehabilitation is crucial in the treatment of people with Parkinson's disease (PD) as it can ameliorate motor and non-motor impairments, improving their clinical profile and quality of life. Considering the complex biological processes occurring in PD brain, the identification of accessible and measurable biomarkers to monitor the events induced by intensive rehabilitation would help in i)testing rehabilitation effectiveness, ii)improving the design of clinical trials and iii)personalizing the rehabilitation strategies by the prediction of patients' responsiveness. The objective of this project is the validation of Raman analysis of saliva and salivary extracellular vesicles (EV) for the differential diagnosis of Parkinson's disease (PD) and atypical Parkinsonism. The proposed diagnostic method can be integrated in the preliminary assessment and monitoring of the patient by providing a quickly and repeatable measurable biomarker. In the end, this will bring tothe personalization of the rehabilitation path and provide an indication on the outcome of the rehabilitation treatment.

Conditions

  • Parkinson's Disease and Parkinsonism

Interventions

OTHER

Single saliva collection

1 ml of saliva will be collected with Salivette swabs.

OTHER

Saliva collection, longitudinal

1 ml of saliva will be collected with Salivette swabs. Subjects diagnosed with PD will undergo assessments and saliva sampling before starting rehabilitation treatment (T0), at the end of treatment (T1) and 3 months after the end of treatment (T2).

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria di Cagliari

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Alice Gualerzi, PhD · Fondazione Don Carlo Gnocchi

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320250 on ClinicalTrials.gov