Status:

COMPLETED

Saliva and Extracellular Vesicles for Parkinson's Disease

Lead Sponsor:

Fondazione Don Carlo Gnocchi Onlus

Collaborating Sponsors:

Azienda Ospedaliero Universitaria di Cagliari

Conditions:

Parkinson's Disease and Parkinsonism

Eligibility:

All Genders

50-85 years

Brief 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. Consideri...

Detailed Description

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms such as bradykinesia, tremor, rigidity and postural instability. An accurate rehabilitation program designed co...

Eligibility Criteria

Inclusion

  • For Pakinson's disease: diagnosis following "MDS clinical diagnostic criteria for Parkinson's disease" (Postuma et al. Movement Disorders vol. 30 1591-1601, 2015), with Hoehn\&Yahr between 1 and 3.
  • The diagnosis of Progressive Supranuclear Palsy will be made according to the criteria of the Movement Disorders Society (Höglinger et al. Mov. Disord. 32, 853-864, 2017). The diagnosis of Corticobasal Syndrome will be made according to the 2013 Armstrong criteria (Armstrong et al. Neurology 80, 496-503, 2013).
  • The diagnosis of multiple system atrophy will be made according to the Gilman criteria of The diagnosis of Behavior Disorder in REM phase will be made according to the criteria of the "International Classification of Sleep Disorders, Third Edition (ICSD-3)".

Exclusion

  • For all the experimental groups considered and for healthy controls, subjects with concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic diseases (eg anemia, cardiovascular or respiratory diseases), oncological or infectious diseases will be excluded.
  • Vascular parkinsonisms, monogenic parkinsonisms will also be excluded as well as iatrogenic parkinsonisms, parkinsonisms secondary to exposure to known neurotoxins; parkinsonisms secondary to tumor lesions; parkinsonisms due to normotensive hydrocephalus; subjects with a form of dementia, severe speech disorders and other psychiatric and / or neurological pathologies.

Key Trial Info

Start Date :

December 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

165 Patients enrolled

Trial Details

Trial ID

NCT05320250

Start Date

December 15 2021

End Date

December 31 2024

Last Update

January 13 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Azienda Ospedaliero - Universitaria di Cagliari

Cagliari, Italy

2

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy, 50100

3

IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS

Milan, Italy, 20148

4

Fondazione Don Gnocchi, Centro "S. Maria ai Servi"

Parma, Italy