Disease: Parkinson's disease
Type of study: Interventional trial
Coordinating investigator: Johannes Jernqvist Gaare
Study director: Charalampos Tzoulis
Background: NAD-RBD introduces a groundbreaking approach to combat α-synucleinopathies, relentlessly progressive neurodegenerative disorders, comprising Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). While these conditions currently lack disease-modifying therapies, our research has nominated NAD replenishment as a promising intervention. Key to this strategy is targeting the prodromal phase of α-synucleinopathies, marked by isolated REM sleep Behaviour Disorder (iRBD).
NAD-RBD, a Phase III multi-centre, randomised, double-blind, placebo-controlled study, will evaluate the efficacy of NAD-replenishment therapy in halting the progression of motor and cognitive dysfunction in individuals with iRBD. We plan to enrol 400 participants across 11 centres in Norway and treat them for 24–58 months, with time to motor or cognitive progression milestone or phenoconversion as primary outcome. The adaptive treatment duration will optimise the therapeutic window per individual. The study emphasises personalised medicine, developing biomarkers for disease stratification and prediction of treatment response. The partly decentralised design will minimise patient discomfort and lower operational costs. This pioneering initiative shifts focus from treating to preventing neurodegenerative diseases, potentially easing the burden on patients, caregivers, and healthcare systems while significantly enhancing life quality for millions at risk of α-synucleinopathies.
The primary objective of the project is to assess the clinical efficacy of NR in delaying the progression of motor dysfunction, cognitive dysfunction, or phenoconversion in individuals with iRBD.
Status: The protocol has been established. Recruitment is planned for Q4 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