Principal Investigator: Charalampos Tzoulis
To test the potential of NR as a neuroprotective therapy for PD, we will perform NO-PARK (ClinicalTrials.gov: NCT03568968), a multi-centre, phase II randomized double-blinded clinical trial, comparing NR to placebo in individuals with early stage PD. The central hypothesis of NO-PARK is that oral administration of the NAD precursor NR can boost neuronal NAD levels and ameliorate mitochondrial dysfunction in PD. This, in turn, will rectify neuronal metabolism and inhibit neurodegeneration, resulting in amelioration of clinical symptoms and delayed PD progression.
Individuals with PD (n = 400) will be recruited starting 01/10/2020 from eight centres across all four health regions of Norway: 1) Haukeland University Hospital (HUS, leading site), Bergen; 2) Akershus University Hospital (AHUS), Akershus, Oslo; 3) Ullevål University Hospital (UUH), Oslo; 4) Rikshospitalet (RH), Oslo; 5) Drammen Hospital (DH), Drammen; St. Olavs University Hospital (St. Olavs), Trondheim; 6) University Hospital of North Norway (UNN), Tromsø; 7) Dr Karen Herlofson Practice and Arendal Hospital (AH), Arendal; 8) Førde Central Hospital (FCH), Førde
After the initial assessment, participants will be randomly assigned to either NR 500 mg x 2/day, or placebo and followed with regular clinical examination, brain imaging and blood tests for a total period of one year. This work aims to discover and develop a therapy with the potential to delay the progression of PD.
The primary objective is to determine whether high dose oral NR delays disease progression in PD measured by MDS-UPDRS. Secondary objectives include to determine whether high dose oral NR: a) Improves and/or prevents specific clinical symptoms in PD (e.g. motor and non-motor symptoms, cognitive symptoms, activity of daily living), b) Delays nigrostriatal degeneration (DAT-scan) c) Rectifies NAD metabolism and mitochondrial function, d) Corrects histone hyperacetylation and gene expression profile