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

NCT ID: NCT03568968

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-06
• Study Completion Date: 2025-06-17

Brief Summary

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.

Detailed 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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nicotinamide Riboside

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

Group Type: EXPERIMENTAL

Nicotinamide Riboside

Intervention Type: DIETARY_SUPPLEMENT

Nicotinamide Riboside 500mg administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

Placebo Comparator

Placebo capsules, no active ingredients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

Interventions

Nicotinamide Riboside

Nicotinamide Riboside 500mg administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

Intervention Type: OTHER

Other Intervention Names

NR, NAD, TruNiagen

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Førde Hospital Trust

OTHER

Sponsor Role: collaborator

Helse Fonna

OTHER

Sponsor Role: collaborator

Molde Hospital

OTHER

Sponsor Role: collaborator

Bodø sykehus

UNKNOWN

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: collaborator

Drammen sykehus

OTHER

Sponsor Role: collaborator

University Hospital of Northern Norway, Tromsø, Norway

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charalampos Tzoulis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Bodø Hospital

Bodø, Nordland, Norway

Arendal Hospital

Arendal, , Norway

Haukeland University Hospital

Bergen, , Norway

Vestre Viken Hospital

Drammen, , Norway

Førde sykehus

Førde, , Norway

Haugesund Hospital

Haugesund, , Norway

Molde sjukehus

Molde, , Norway

Akershus university hospital

Oslo, , Norway

Oslo University Hospital

Oslo, , Norway

University Hospital of North Norway

Tromsø, , Norway

Østfold Hospital

Fredrikstad, Østland, Norway

Countries

Norway

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017/2083

Identifier Type: -

Identifier Source: org_study_id