Haukeland University Hospital
Bergen, Hordaland, 5021, Norway
NCT Number: NCT03816020
1. Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET). 2. Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD. 3. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bergen, Hordaland, 5021, Norway
Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nicotinamide Riboside capsules 250mg x 2 BID
Placebo capsules BID
Time frame: 4 weeks
The primary outcome will be the between-group difference in Parkinson's disease related pattern (PDRP) measured by FDG-PET comparing baseline and 3-4 week follow-up measurement.
Time frame: 4 weeks
Clinical changes measured by MDS-UPDRS from using NR
Time frame: 4 weeks
To measure NAD a liquid chromatography/tandem mass spectrometry will be use (abrv platform for method is LC-MS/MS.) We are interested in change of value of NAD. There is to our knowledge no measured NAD levels of PD patients. See PMID: 29184669 for the same method that we will use.
Haukeland University Hospital
Other
NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
Acronym: NAD-PARK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05538455
Alzheimer Disease, Basal Ganglia Diseases
Milan, MI, Italy
View Trial DetailsNCT00537017
Basal Ganglia Diseases, Brain Diseases
View Trial DetailsNCT03295786
Basal Ganglia Diseases, Brain Diseases
Helsinki, Finland
View Trial DetailsNCT00406029
Basal Ganglia Diseases, Brain Diseases
View Trial Details