Disease: Parkinson's disease
Type of study: Observational trial
Coordinating investigator: Johannes Jernqvist Gaare
Study director: Charalampos Tzoulis
Background:
α-synucleinopathies are an important group of relentlessly progressive, debilitating, and incurable neurodegenerative disorders, comprising Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). Before the diseases become clinically manifest, they are preceded by a long prodromal phase that can last up to 20 years. Current treatments make no impact on disease progression, and trials of potential disease-modifying therapies have so far been unsuccessful. There is a need to shift our efforts from treatment to prevention by initiating interventions in the prodromal phase of the disease.
REM-sleep behaviour disorder (RBD) is a parasomnia, characterised by loss of muscle atonia during REM-sleep, resulting in dream enactment. Isolated RBD (iRBD, i.e. RBD without other overt neurodegenerative manifestations) is associated with an exceedingly high risk of future development of an α-synucleinopathy and is considered to be the most specific marker of being in the prodromal stage of an α-synucleinopathy. After 15 years, > 90% of individuals with iRBD will have developed PD, DLB or MSA.
The NOR-RBD platform is an initiative with three main goals: 1) establish a longitudinal cohort of individuals with iRBD to facilitate the development of predictive biomarkers for risk stratification; 2) establish a structured health care program for individuals in the prodromal stages of α-synucleinopathies; 3) initiate neuroprotective clinical trials in iRBD patients.
The overarching objective of the project is to establish the NOR-RBD platform for longitudinal follow up for patients with prodromal α-synucleinopathy (as defined by the presence of iRBD) and initiate neuroprotective clinical trials.
Status: The study received funding to start, and the protocol has been established. Recruitment will start in Q2 2025.
Participating centres
- Haukeland University Hospital, Bergen
- Akershus University Hospital, Lørenskog
- Oslo University Hospital, Oslo
- Vestre Viken Hospital, Drammen
- Østfold Hospital, Kalnes
- Nordland Hospital, Bodø
- University Hospital of North Norway, Tromsø
- Førde Hospital, Førde
- Dr. Karen Herlofson, Arendal
- Sørlandet Hospital, Arendal
- Haugesund Hospital, Haugesund
- Molde Hospital, Molde
Funding
- The Regional Health Authority of Western Norway
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- Participating hospitals