Disease: Parkinson's disease
Type of study: Interventional trial
Coordinating investigator: Haakon Berven
Study director: Charalampos Tzoulis
Background: While our previous findings nominate NR as therapy for PD, the observed effects were heterogeneous across the study population, raising the question of individualised dose-dependent responses. Thus, the optimal NR dose for neurological intervention is unknown. N-DOSE is a dose-optimisation trial of NR in PD, which will address this important knowledge gap.
The objective of the N-DOSE study is to determine the Optimal Biological Dose (OBD) for NR, defined as the dose required to achieve maximal cerebral NAD increase (measured by 31P-MRS or CSF metabolomics), or maximal alteration in cerebral metabolism patterns (measured by FDG-PET), or maximal proportion of MRS-responders, in the absence of unacceptable toxicity.
Design: N-DOSE is a randomised double-blinded placebo-controlled trial (RCT) to assess the optimal biological dose for nicotinamide riboside (NR) in PD. Individuals with PD (n = 80) will be randomised in a 1:1:2 ratio to three groups: placebo, 1000 mg NR daily, or a dose escalation group starting with 1000 mg daily and escalate to 2000 mg and 3000 mg at one-month intervals. Measures will include clinical, neuroimaging (31P-MRS, FDG-PET), molecular, and biochemical endpoints. Study duration will be three months.
Primary endpoint: The between-visit change in cerebral NAD levels measured by 31P-MRS).
Status: The study is fully enrolled and will be concluded in May 2025.
Participating centre
- Haukeland University Hospital, Bergen
Funding
- The Research Council of Norway, Neuro-SysMed
- The Research Council of Norway, KOMMERSFORSK
- The Regional Health Authority of Western Norway
- The Norwegian Parkinson’s Disease Association
- Haukeland University Hospital