Disease: Parkinson's disease
Type of study: Interventional trial
Coordinating investigator: Christian Dölle
Study director: Charalampos Tzoulis
Background: To further develop the potential of NAD-replenishment therapy (NRT) as a neuroprotective therapy, we need to determine the optimal dosing regimen, including dose size and frequency. The NADbrain study will determine the optimal dosing regimen by performing a parallel assessment of NRT pharmacokinetics in the blood and brain of healthy human subjects and subjects with Parkinson’s disease (PD).
The primary objective of the NADbrain study is to determine the blood and brain pharmacokinetics of NAD replenishment therapy (NRT) using Nicotinamide Riboside (NR) or Nicotinamide Mononucleotide (NMN).
Design: The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects. A total of 6 healthy individuals (3 men and 3 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound.
Moreover, a total of 6 healthy individuals (3 men and 3 women) and 6 individuals with PD (3 men and 3 women) will receive NR 1200 mg daily (600 mg x 2) for 4 weeks, with a total measurement/assessment period of 7 weeks, and undergo repeated blood sampling and 31P-MRS brain scans once per week during this time.
Blood will be analysed for NAD-metabolites. The simultaneous change in NAD-metabolism over time in blood and brain will be assessed and blood and brain pharmacokinetics for NRT in humans will be established.
Primary endpoint: The change of cerebral NAD levels (measured by 31P-MRS) and of blood NAD-metabolites (measured by NADmed assay), over time, after the administration of oral NRT with the NAD precursors NR 600 mg x 2 daily or NMN 600 mg x 2 daily.
Status: The study was completed in 2024, and the results submitted for publication.
Participating centre
- Haukeland University Hospital, Bergen
Funding
- The Norwegian Parkinson’s Disease Association
- The Research Council of Norway, Neuro-SysMed
- The Research Council of Norway, KOMMERSFORSK
- The Regional Health Authority of Western Norway
- Haukeland University Hospital