A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease (NOPARK)
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|ClinicalTrials.gov Identifier: NCT03568968|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : December 10, 2018
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 :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized double-blinded study. 200 Participants randomized in 1:1 ratio to either vitamine supplementation or placebo.|
|Masking:||Double (Participant, 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|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
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.
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).
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|
|Principal Investigator:||Charalampos Tzoulis, MD, PhD||Haukeland University Hospital|