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

Haukeland University Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Parkinson Disease

Treatments: Other: Placebo; Dietary Supplement: Nicotinamide Riboside

Study type: Interventional

Funder types: Other

Identifiers

NCT03568968

2017/2083

Details and patient eligibility

About

NOPARK is a double-blinded randomized controlled phase II trial, with the aim to assess the efficacy of nicotinamide adenine dinucleotide (NAD)-replenishment therapy in the form of oral nicotinamide riboside (NR) in delaying the progression of early Parkinson's disease (PD). A total of 400 persons with early stage Parkinson's disease will be enrolled, randomized on nicotinamide riboside (NR) 500mg x 2 per day or placebo, and followed for 52 weeks.

Full description

NOPARK is a multi-center, double-blinded randomized controlled trial, with the aim to assess the efficacy of NAD-replenishment therapy in the form of oral nicotinamide riboside (NR) in delaying the progression of early Parkinson's disease (PD). Individuals with PD (n = 400) will be recruited from multiple centers across Norway. Eligible participants must have been diagnosed with PD within 2 years of study enrollment and meet the trial's inclusion criteria. All participants will be given a standard PD-treatment regimen comprising selegiline 10 mg/day and oral levodopa (Sinemet or Madopar) at a dose of 100mg x 3, 150mg x3, or 200mg x 3 per day. The PD-treatment regimen will be frozen at baseline and remain stable throughout the duration of the study. At baseline, participants will be randomized on a 1:1 ratio on either nicotinamide riboside (NR) 500mg x 2 per day or placebo. Both the participants and the investigators will be blinded. The trial duration will be 52 weeks, during which participants will be assessed at baseline, 13, 26, 39 and 52 weeks. Measures include clinical evaluation using established scales for motor and non-motor dysfunction, as well as quality of life, 123I-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl) nortropane ([¹²³I]FP-CIT) single photon emission tomography (DaTscan), magnetic resonance imaging (MRI) of the brain, blood safety tests, and blood sampling for metabolomics, transcriptomics, and other exploratory analyses. The primary outcome of the study is the total score of the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Enrollment: 400 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease
• [¹²³I]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
• Diagnosed with PD within 2 years from enrolment
• Hoehn and Yahr score < 3 at enrolment
• Optimal symptomatic therapy, not requiring adjustments, for at least 1 month.
• Age equal to or greater than 35 years at time of enrolment.

Exclusion criteria

• Dementia or other neurodegenerative disorder at baseline visit
• Diagnosed with atypical parkinsonism or vascular parkinsonism
• Any psychiatric disorder that would interfere with compliance in the study.
• Any severe somatic illness that would make the individual unable to comply and participate in the study.
• Use of high dose vitamin B3 supplementation within 30 days of enrolment
• Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
• Genetically confirmed mitochondrial disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Nicotinamide Riboside

Experimental group

Description:

nicotinamide riboside, 1000mg daily for the duration of the trial (52 weeks). Dosage form is capsules.

Treatment:

Dietary Supplement: Nicotinamide Riboside

Placebo Comparator

Placebo Comparator group

Description:

Placebo capsules, no active ingredients.

Treatment:

Other: Placebo