A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease (NOPARK)
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- STATUS
- Recruiting
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- End date
- Mar 15, 2024
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- participants needed
- 400
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- sponsor
- Haukeland University Hospital
Summary
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.
Description
Individuals with PD (n = 200) will be recruited starting 01/09/2019. Newly diagnosed and/or treatment nave patients will be given Selegiline 10 mg/day PO and Sinemet 100 x 3. Treatment efficacy will be assessed upon reexamination every 1 month. If adequate symptomatic relief is not achieved, the dopaminergic therapy may be increased by 150 mg levodopa until optimal effect or a maximum dose of Sinemet 200 x 3. If adequate symptomatic relief is not achieved on this dose, the patient will excluded and further followed-up at the regular outpatient service. Once optimal effect is reached (i.e. stable treatment for at least 3 months, the regime will be frozen for the duration of the study period (52 weeks). Patients will then be randomized to receive either Nicotamide riboside or placebo. Both the participants and the investigators are masked. The trial will have a 52 weeks (1 year) exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. In addition, all patients will take a stable regime of selegiline 10 mg/day plus optimal dopaminergic therapy. After the baseline visit, participants will be reassessed at 4, 13, 26, 39 and 52 weeks in person. Clinical evaluation will be performed by one of the neurologists involved in the study and/or the study nurse. The primary outcome of the study is the total score of the Movement disorder society Unified parkinson's disease rating scale (MDS-UPDRS) comparing the NR and and placebo group.
Details
| Condition | Parkinson Disease |
|---|---|
| Treatment | Placebo, Nicotinamide Riboside |
| Clinical Study Identifier | NCT03568968 |
| Sponsor | Haukeland University Hospital |
| Last Modified on | 25 January 2022 |
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