A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease (NOPARK)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2024
  • participants needed
    400
  • sponsor
    Haukeland University Hospital
Updated on 25 January 2022
malnutrition
datscan
early parkinson's

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 IdentifierNCT03568968
SponsorHaukeland University Hospital
Last Modified on25 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease
Positive [I]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

Exclusion Criteria

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
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