Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution

RecruitingOBSERVATIONAL
Enrollment

1,200

Participants

Timeline

Start Date

May 12, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

April 30, 2029

Conditions
Parkinson Disease (PD)
Interventions
OTHER

Blood draw for the laboratory assessment

Participants' clinical histories will be reviewed at T0 (baseline) and T1 (24 months). They will also undergo a clinical assessment at T0 and T1. The assessments will be tailored based on whether the participant belongs to the PD or non-PD group, as outlined below: • MDS-UPDRS + H\&Y: Used to evaluate the neurological domain, applied to the PD group. • BERG: Used to assess balance and performance, applied to both PD and non-PD groups. • CIRS-G: Used to evaluate comorbidities, applied to both PD and non-PD groups. • PD-CRS: Used to assess cognitive function, applied to the PD group. • MMSE (temporal and spatial orientation only): Used to assess cognitive function, applied to both PD and non-PD groups. • PDQ-8: Used to evaluate quality of life, applied to the PD group. • PD-CFRS: Used for functional assessment, applied to the PD group. • GDS: Used to assess depression, applied to both PD and non-PD groups. Blood samples will be collected at T0 and T1, with 20 mL drawn per participant.

Trial Locations (4)

20144

RECRUITING

Casa di Cura Igea, Milan

28014

NOT_YET_RECRUITING

Asociacion Parkinson Madrid, Madrid

54124

NOT_YET_RECRUITING

Aristotle University of Thessaloniki, Thessaloniki

02-957

NOT_YET_RECRUITING

Instytut Psychiatrii I Neurologii, Warsaw

Sponsors
All Listed Sponsors
collaborator

Asociación Parkinson Madrid

OTHER

collaborator

Aristotle University Of Thessaloniki

OTHER

collaborator

Institute of Psychiatry and Neurology, Warsaw

OTHER

collaborator

LINKCARE HEALTH SERVICES SL

UNKNOWN

collaborator

ALMAWAVE SPA

UNKNOWN

collaborator

European Brain Research Foundation

UNKNOWN

lead

Casa di Cura IGEA

OTHER