NCT07729748Active, not recruiting
Predicting Parkinson's Disease Before It Strikes: A Brain Imaging Study in At-Risk Individual
Tracking and Predicting Neurodegeneration Along the Parkinson's Disease Continuum Using Clinical, Cognitive and Advanced MRI Data
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- 4 Dec 2020
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Parkinson disease
- NCT number
- NCT07729748
What you commit to
- Study type: Observational
- Planned participants: 100
- From 4 Dec 2020 to the primary completion date, 1 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol and/or psychotropic drugs abuse.
- Alcohol and/or psychotropic drugs abuse.
- Hypnotic or benzodiazepine medication.
Other illness
- History of other systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan.
- Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia).
- Sleep disorders on the basis of clinical evaluation.
- History of systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan.
- Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia).
Other
- Secondary forms of RBD on the basis of historical data, neurologic examination, and cerebral MRI findings.
Who the study is looking for
- Right-handed participants.
- Monolingual native Italian speakers.
- Age between 50 and 75 years old.
- Normal or corrected-to-normal visual acuity.
- Mini Mental State Examination (MMSE) score greater than 24.
- Oral and written informed consent to study participation.
- Additional inclusion criteria for iRBD patients:
- Diagnosis of iRBD based on International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria: presence of REM sleep without atonia; presence of sleep-related injurious-disruptive behaviors by history or abnormal sleep behaviors documented during PSG monitoring; absence of EEG epileptiform activity during REM sleep; presence of sleep disturbance not better explained by another sleep disorder, medical or neurologic disorder, mental disorder, medication use, or substance use disorder.
- PSG-confirmed iRBD duration since diagnosis equal or greater than 5 years.
- Absence of clinically defined Parkinson's disease.
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Neurology Unit - Neuroimaging Research Unit Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| San Raffaele Hospital - Sleep Disorders Center, Department of Neurology, Turro Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.