Clinical Trial

Predicting Parkinson's Disease Before It Strikes: A Brain Imaging Study in At-Risk Individual

Study acronym: iRBD
Active, Not Recruiting
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Summary
This study aims to characterize neurodegeneration progression in patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD) and to develop a prognostic model for clinical evolution and earlier identification of cases at risk of short-term conversion to clinically defined Parkinson's disease (PD). The study uses a multiparametric approach combining longitudinal clinical, neuropsychological, quantitative PSG, and multiparametric brain MRI markers (structural MRI, diffusion tensor imaging, resting-state functional MRI) to track neurodegeneration from the prodromal stage of PD and predict individual disease evolution. 50 patients with PSG-confirmed iRBD (duration since diagnosis greater than or equal to 5 years) and 50 age- and sex-matched healthy controls will be assessed at baseline and every year for 3 years at IRCCS Ospedale San Raffaele, Milan, Italy.
Trial Details
NCT Number NCT07729748
Lead Sponsor IRCCS San Raffaele
Conditions Idiopathic REM Sleep Behavior Disorder, Parkinson Disease, Neurodegeneration, Prodromal Parkinson Disease
Enrollment 100 participants
Start Date 2020-12-04
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28