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

• Status: Recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

1. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease.

2. Positive [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration

3. Diagnosed within one year from enrolment

4. Hoehn and Yahr score <= 2 at enrolment

5. Optimal symptomatic therapy, not requiring adjustments, for at least 3 months

Exclusion Criteria:

1. Dementia or other neurological disorder at baseline visit

2. Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit

3. Prior use of dopaminergic treatment