Idiopathic REM Sleep Behavior DisorderiRBDNCT07729748
Predicting Parkinson's Disease Before It Strikes: A Brain Imaging Study in At-Risk Individual
An observational study of Idiopathic REM Sleep Behavior Disorder and Parkinson Disease, run by IRCCS San Raffaele at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic REM Sleep Behavior Disorder, Parkinson Disease, Neurodegeneration
- What is being tested?
- Multiparametric clinical, neuropsychological, PSG and MRI assessment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Dec 2020to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with PSG-confirmed longstanding iRBD (duration since diagnosis greater than or equal to 5 years) recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan, Italy. Healthy controls recruited among non-consanguineous relatives, institute personnel and by word of mouth.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- Secondary forms of RBD on the basis of historical data, neurologic examination, and cerebral MRI findings.
- History of other systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan.
- Alcohol and/or psychotropic drugs abuse.
- 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.
Show all 9Show fewer
- Alcohol and/or psychotropic drugs abuse.
- 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).
- Hypnotic or benzodiazepine medication.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Raffaele Hospital - Sleep Disorders Center, Department of Neurology, Turro
Milan, Milano, 20127
San Raffaele Neurology Unit - Neuroimaging Research Unit
Milan, Milano, 20132
About this study
Official title: Tracking and Predicting Neurodegeneration Along the Parkinson's Disease Continuum Using Clinical, Cognitive and Advanced MRI Data
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.
Read the detailed description
Parkinson's disease (PD) is a chronic, debilitating neurodegenerative disorder characterized by progressive motor dysfunction and various non-motor features. Better understanding and prediction of PD progression from the earliest stage will improve disease management and clinical trial design.
Idiopathic REM sleep behavior disorder (iRBD) is the most specific marker of prodromal PD, since the majority of individuals with iRBD eventually develop PD or a related synucleinopathy. Longitudinal studies have shown that the estimated risk for the clinical diagnosis of a synucleinopathy from the time of iRBD diagnosis is about 35% at 5 years, 75% at 10 years, and 90% at 14 years. Therefore, studying iRBD provides a unique window to observe neurodegenerative synucleinopathies in their prodromal stages, before parkinsonism or dementia becomes fully manifest.
This is a national, monocentric, longitudinal observational study with additional procedures. Patients with iRBD will be screened to evaluate eligibility: patients will be included if they have PSG-confirmed longstanding iRBD duration since diagnosis equal or greater than 5 years, without a clinically defined PD.
All patients undergo clinical and cognitive assessments, quantitative PSG, and MRI visits at baseline (T0) and every year for 3 years. PSG is performed to diagnose iRBD and investigate PSG changes over time. MRI evaluations investigate structural alterations and resting-state (RS) functional connectivity. Longitudinal measures of cortical/subcortical atrophy, white matter damage, and RS connectivity will be assessed.
A group of 50 healthy subjects similar for age (50-75 years old) and sex to patients with iRBD will be recruited. They will undergo clinical evaluation and PSG at study entry (to exclude sleep disorders), and motor, neuropsychological and MRI assessments at baseline and every year for 3 years.
Clinical assessments include: Unified Parkinson's Disease Rating Scale (UPDRS), Single-Question Screen for REM sleep behavior disorder, REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Beck Depression Inventory-II (BDI-II).
Motor assessments include: Five Times Sit-To-Stand, Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), TUG with cognitive task, Nine Hole Peg Test.
Neuropsychological assessments include: MMSE, Digit span forward and backward, Corsi block-tapping test, Rey's List, Raven's Progressive Matrices, Trail Making Test A and B (TMT-A and TMT-B), Attentive Matrices, Verbal Fluency (phonemic and semantic cues), Token Test, Copy of Rey-Osterrieth complex figure.
PSG recording includes: electroencephalogram (six channels), electrooculogram, electromyography (submentalis muscle and bilateral tibialis anterior muscles), electrocardiogram, and sleep respiratory pattern.
Brain MRI sequences include: 3D sagittal T1-weighted fast field echo (structural MRI), diffusion tensor (DT) MRI, and T2*-weighted EPI sequence for resting-state fMRI.
Statistical analyses include: t-test, Mann-Whitney U-test or Pearson chi-square for between-group comparisons; longitudinal linear generalized models for repeated measures or Wilcoxon test for within-group changes over time; multivariable linear mixed-effects models for predictors of motor/nonmotor progression; multivariable Cox model for predictors of conversion to full clinical disease in iRBD.
- Conditions
- Idiopathic REM Sleep Behavior Disorder, Parkinson Disease, Neurodegeneration, Prodromal Parkinson Disease
- Being tested
- Multiparametric clinical, neuropsychological, PSG and MRI assessment
- Keywords
- REM sleep behavior disorder, iRBD, Parkinson's disease, Neurodegeneration, MRI, Polysomnography, Prodromal Parkinson, Diffusion tensor imaging, Resting-state fMRI, Prognostic model, Cognitive assessment
- Medical subject headings
- Parkinson Disease, Nerve Degeneration, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric clinical, neuropsychological, PSG and MRI assessmentOther
All participants undergo multiparametric longitudinal assessments at baseline and every year for 3 years, including: clinical and neuropsychological evaluation, motor assessment using inertial sensors, quantitative polysomnography (PSG) recording, and multiparametric brain MRI on a 3.0 Tesla system (Ingenia CX Philips) including 3D T1-weighted structural MRI, diffusion tensor (DT) MRI, and resting-state fMRI.
Healthy controls undergo PSG at baseline only (to exclude sleep disorders) and motor, neuropsychological and MRI assessments at baseline and every year for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Patients with iRBD | 50 patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD), with iRBD duration since diagnosis equal or greater than 5 years, without a clinically defined Parkinson's disease. Recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan. Receives: Other: Multiparametric clinical, neuropsychological, PSG and MRI assessment | |
| Healthy Controls | 50 healthy subjects similar for age (range 50-75 years old) and sex to patients with iRBD, recruited among non-consanguineous relatives, institute personnel and by word of mouth. They undergo PSG at study entry to exclude sleep disorders. Receives: Other: Multiparametric clinical, neuropsychological, PSG and MRI assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
A prognostic model based on longitudinal clinical markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
Measured: Baseline, 12 months, 24 months, and 36 months
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
A prognostic model based on longitudinal neuropsychological markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
Measured: Baseline, 12 months, 24 months, and 36 months
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
A prognostic model based on longitudinal PSG markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
Measured: Baseline, 12 months, 24 months, and 36 months
Secondary outcomes (11)
Longitudinal change in neuropsychological performance (MMSE)
Changes over time in Minimental Examination Score
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Five Times Sit-To-Stand)
Changes over time in motor assessment scores including Five Times Sit-To-Stand
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Ten-Meter Walking Test)
Changes over time in motor assessment scores including Ten-Meter Walking Test (10MWT),
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Timed Up and Go Test)
Changes over time in motor assessment scores including Timed Up and Go Test (TUG)
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (TUG with Cognitive Task)
Changes over time in motor assessment scores including TUG with Cognitive Task (TUG-COG)
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in PSG parameters (sleep stages)
Changes over time in quantitative PSG parameters including sleep stages in patients with iRBD
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in PSG parameters (REM sleep without atonia)
Changes over time in quantitative PSG parameters including REM sleep without atonia in patients with iRBD.
Measured: Baseline, 12 months, 24 months, and 36 months
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor MRI
Longitudinal change in fractional anisotropy (FA), a measure of white matter microstructural integrity derived from diffusion tensor imaging (DTI), assessed at baseline, 12, 24, and 36 months using linear mixed-effects models. Decreased FA values indicate greater white matter damage
Measured: Baseline, 12 months, 24 months, and 36 months
Change in Resting-State Functional Connectivity Strength Between Brain Networks Measured by fMRI
Longitudinal change in resting-state functional connectivity strength between predefined brain networks, quantified as the Fisher z-transformed correlation coefficient between BOLD signal time series of regions of interest, assessed using T2*-weighted EPI fMRI sequences. Changes over time are analyzed using linear mixed-effects models in patients with iRBD compared to age- and sex-matched healthy controls.
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in UPDRS score
Changes over time in the Unified Parkinson's Disease Rating Scale (UPDRS) score assessing motor symptoms associated with PD in iRBD patients.
Measured: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in UPDRS score
Changes over time in the Unified Parkinson's Disease Rating Scale (UPDRS) score assessing non- motor symptoms associated with PD in iRBD patients.
Measured: Baseline, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start4 Dec 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
- Investigators
- Massimo Filippi, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729748
- Sponsor's protocol ID
- RF-2018-12366746
- Acronym
- iRBD
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking and Predicting Neurodegeneration Along the Parkinson's Disease Continuum Using Clinical, Cognitive and Advanced MRI Data
- ClinicalTrials.gov ID
- NCT07729748
- Acronym / sponsor ID
- iRBD / RF-2018-12366746
- Conditions
- Idiopathic REM Sleep Behavior Disorder, Parkinson Disease, Neurodegeneration, Prodromal Parkinson Disease
- Keywords
- REM sleep behavior disorder, iRBD, Parkinson's disease, Neurodegeneration, MRI, Polysomnography, Prodromal Parkinson, Diffusion tensor imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Parkinson's disease (PD) is a chronic, debilitating neurodegenerative disorder characterized by progressive motor dysfunction and various non-motor features. Better understanding and prediction of PD progression from the earliest stage will improve disease management and clinical trial design.
Idiopathic REM sleep behavior disorder (iRBD) is the most specific marker of prodromal PD, since the majority of individuals with iRBD eventually develop PD or a related synucleinopathy. Longitudinal studies have shown that the estimated risk for the clinical diagnosis of a synucleinopathy from the time of iRBD diagnosis is about 35% at 5 years, 75% at 10 years, and 90% at 14 years. Therefore, studying iRBD provides a unique window to observe neurodegenerative synucleinopathies in their prodromal stages, before parkinsonism or dementia becomes fully manifest.
This is a national, monocentric, longitudinal observational study with additional procedures. Patients with iRBD will be screened to evaluate eligibility: patients will be included if they have PSG-confirmed longstanding iRBD duration since diagnosis equal or greater than 5 years, without a clinically defined PD.
All patients undergo clinical and cognitive assessments, quantitative PSG, and MRI visits at baseline (T0) and every year for 3 years. PSG is performed to diagnose iRBD and investigate PSG changes over time. MRI evaluations investigate structural alterations and resting-state (RS) functional connectivity. Longitudinal measures of cortical/subcortical atrophy, white matter damage, and RS connectivity will be assessed.
A group of 50 healthy subjects similar for age (50-75 years old) and sex to patients with iRBD will be recruited. They will undergo clinical evaluation and PSG at study entry (to exclude sleep disorders), and motor, neuropsychological and MRI assessments at baseline and every year for 3 years.
Clinical assessments include: Unified Parkinson's Disease Rating Scale (UPDRS), Single-Question Screen for REM sleep behavior disorder, REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Beck Depression Inventory-II (BDI-II).
Motor assessments include: Five Times Sit-To-Stand, Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), TUG with cognitive task, Nine Hole Peg Test.
Neuropsychological assessments include: MMSE, Digit span forward and backward, Corsi block-tapping test, Rey's List, Raven's Progressive Matrices, Trail Making Test A and B (TMT-A and TMT-B), Attentive Matrices, Verbal Fluency (phonemic and semantic cues), Token Test, Copy of Rey-Osterrieth complex figure.
PSG recording includes: electroencephalogram (six channels), electrooculogram, electromyography (submentalis muscle and bilateral tibialis anterior muscles), electrocardiogram, and sleep respiratory pattern.
Brain MRI sequences include: 3D sagittal T1-weighted fast field echo (structural MRI), diffusion tensor (DT) MRI, and T2*-weighted EPI sequence for resting-state fMRI.
Statistical analyses include: t-test, Mann-Whitney U-test or Pearson chi-square for between-group comparisons; longitudinal linear generalized models for repeated measures or Wilcoxon test for within-group changes over time; multivariable linear mixed-effects models for predictors of motor/nonmotor progression; multivariable Cox model for predictors of conversion to full clinical disease in iRBD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with iRBD | – | Other: Multiparametric clinical, neuropsychological, PSG and MRI assessment50 patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD), with iRBD duration since diagnosis equal or greater than 5 years, without a clinically defined Parkinson's disease. Recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan. |
| Healthy Controls | – | Other: Multiparametric clinical, neuropsychological, PSG and MRI assessment50 healthy subjects similar for age (range 50-75 years old) and sex to patients with iRBD, recruited among non-consanguineous relatives, institute personnel and by word of mouth. They undergo PSG at study entry to exclude sleep disorders. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PSG-confirmed longstanding iRBD (duration since diagnosis greater than or equal to 5 years) recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan, Italy. Healthy controls recruited among non-consanguineous relatives, institute personnel and by word of mouth.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- Secondary forms of RBD on the basis of historical data, neurologic examination, and cerebral MRI findings.
- History of other systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan.
- Alcohol and/or psychotropic drugs abuse.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric clinical, neuropsychological, PSG and MRI assessmentAll participants undergo multiparametric longitudinal assessments at baseline and every year for 3 years, including: clinical and neuropsychological evaluation, motor assessment using inertial sensors, quantitative polysomnography (PSG) recording, and multiparametric brain MRI on a 3.0 Tesla system (Ingenia CX Philips) including 3D T1-weighted structural MRI, diffusion tensor (DT) MRI, and resting-state fMRI. Healthy controls undergo PSG at baseline only (to exclude sleep disorders) and motor, neuropsychological and MRI assessments at baseline and every year for 3 years. | Other | Healthy Controls, Patients with iRBD |
Primary outcome
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
Time frame: Baseline, 12 months, 24 months, and 36 months
A prognostic model based on longitudinal clinical markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
Time frame: Baseline, 12 months, 24 months, and 36 months
A prognostic model based on longitudinal neuropsychological markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease
Time frame: Baseline, 12 months, 24 months, and 36 months
A prognostic model based on longitudinal PSG markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
11 secondary outcomes
Longitudinal change in neuropsychological performance (MMSE)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Five Times Sit-To-Stand)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Ten-Meter Walking Test)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (Timed Up and Go Test)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in motor performance (TUG with Cognitive Task)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in PSG parameters (sleep stages)
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in PSG parameters (REM sleep without atonia)
Time frame: Baseline, 12 months, 24 months, and 36 months
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor MRI
Time frame: Baseline, 12 months, 24 months, and 36 months
Change in Resting-State Functional Connectivity Strength Between Brain Networks Measured by fMRI
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in UPDRS score
Time frame: Baseline, 12 months, 24 months, and 36 months
Longitudinal change in UPDRS score
Time frame: Baseline, 12 months, 24 months, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Filippi principal investigator
IRCCS San Raffaele
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic REM Sleep Behavior Disorder and Parkinson Disease, run by IRCCS San Raffaele at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease (time frame: Baseline, 12 months, 24 months, and 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.