A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease (NOPARK)
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|ClinicalTrials.gov Identifier: NCT03568968|
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : June 9, 2020
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NOPARK is a double-blinded randomized controlled trial that studies nicotinamide supplementation in early Parkinson's disease.
Parkinson's disease (PD) is a major cause of death and disability and has a worldwide socioeconomic impact. It affects ~2% of the population above the age of 65 years and its prevalence increases dramatically as the population ages. The etiology and molecular pathogenesis underlying PD remain unknown. Recent evidence has implicated an impaired neuronal metabolism due to mitochondrial dysfunction, in particular NAD-deficiency is a key-event in the pathogenesis of PD. We propose that in order to correct this metabolic defect and treat PD, we need to boost neuronal NAD levels. This would improve mitochondrial function and could slow PD progression. Nicotinamide riboside is a precursor NAD vitamin. In this study we will investigate if nicotinamide riboside supplementation will correct NAD deficiency and thereby slow progression of PD symptoms. This study will recruit 200 patients with newly diagnosed PD and randomly assign them in an 1:1 ratio to either nicotinamide riboside or placebo administration for 52 weeks. During this trial the investigators will determine if nicotinamide riboside delays PD disease progression measured by clinical monitoring tools (MDS-UPDRS). Patients receiving nicotinamide riboside supplementation will receive a daily dose of 1000mg for the duration of the trial. This trial will also collect biological material from participants to see if nicotinamide riboside supplementation rectifies NAD deficiency and metabolism deficiencies.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Dietary Supplement: Nicotinamide Riboside Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized double-blinded study. 400 Participants randomized in 1:1 ratio to either vitamine supplementation or placebo.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Both patients and all investigators are blinded during the trial and during data analysis.|
|Official Title:||A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK Study|
|Actual Study Start Date :||May 15, 2020|
|Estimated Primary Completion Date :||May 15, 2023|
|Estimated Study Completion Date :||March 15, 2024|
Experimental: Nicotinamide Riboside
nicotinamide riboside, 1000mg daily for the duration of the trial (52 weeks). Dosage form is tablets.
Dietary Supplement: Nicotinamide Riboside
1000mg one time daily. Given as tablets. Duration of the trial, 52 weeks.
Other Name: Chromadex NR
Placebo Comparator: Placebo Comparator
Placebo tablets, no active ingredients.
Placebo drug, given 1 time daily for the duration of the trial; 52 weeks.
- MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale) [ Time Frame: 52 weeks ]Clinical rating scale approved by mobement disorder society. The Movement Disorder Society Unified Parkinson's Disease rating Scale (MDS-UPDRS) measures multiple clinical disabilities on a scale of 1-4. The subscores are summed providing a total score for MDS-UPDRS. The total score ranges from 0 to 260. Higher score indicates worse outcome.
- NAD metabolism [ Time Frame: 52 weeks ]Levels of metabolites in the NAD metabolites measured from biological material (blood).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease.
- Positive [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
- Diagnosed within one year from enrolment
- Hoehn and Yahr score <= 2 at enrolment
- Optimal symptomatic therapy, not requiring adjustments, for at least 3 months
- Dementia or other neurological disorder at baseline visit
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
- Prior use of dopaminergic treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568968
|Contact: Charalampos Tzoulis, MD, PhD||94392305 ext +email@example.com|
|Contact: Brage Brakedal, MD||99777962 ext +firstname.lastname@example.org|
|Contact: Karen Herlofsen Karen.Herlofson@sshf.no|
|Haukeland University Hospital||Recruiting|
|Contact: Charalampos Tzoulis, PhD charalampos.Tzouolis@helse-bergen.no|
|Sub-Investigator: Brage Brakedal, MD|
|Vestre Viken Hospital||Not yet recruiting|
|Contact: Kari Anne Bjørnarå, PhD email@example.com|
|Førde sykehus||Not yet recruiting|
|Contact: Aliaksei Labusau firstname.lastname@example.org|
|Haugesund Hospital||Not yet recruiting|
|Contact: Ida Hogenesch neke.Hogenesch@helse-fonna.no|
|Akershus university hospital||Not yet recruiting|
|Contact: Krisztina Kunszt Johansen, PhD email@example.com|
|Oslo University Hospital||Not yet recruiting|
|Contact: Mathias Toft Mathias.Toft@uio.no|
|St. Olavs Hospital||Not yet recruiting|
|Contact: Bjørg Warø firstname.lastname@example.org|
|Principal Investigator:||Charalampos Tzoulis, MD, PhD||Haukeland University Hospital|
|Responsible Party:||Haukeland University Hospital|
|Other Study ID Numbers:||
|First Posted:||June 26, 2018 Key Record Dates|
|Last Update Posted:||June 9, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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