An interventional study of Nicotinamide Riboside and Placebo in Parkinson Disease and Neurodegenerative Diseases, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Basic science
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days
Dietary Supplement: Nicotinamide Riboside
Participant receiving Placebo BIDfor 30 days
Other: Placebo
Nicotinamide Riboside capsules 250mg x 2 BID
Placebo capsules BID
PDRP changes from NR use
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
Motoric change of symptoms from NR use
Clinical changes measured by MDS-UPDRS from using NR
Time frame: 4 weeks
Determine whether high dose oral NR rectifies NAD metabolism in body fluids and muscle tissue.
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.
Time frame: 4 weeks
Plan to share: No — Data will only be shared if there is scientific collaboration. Will not be publicaly shared.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Haukeland University Hospital