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

NCT03568968 | Completed Phase 3 DMC

• 1 other identifier: 2017/2083
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 11

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; NAD metabolism; Mitochondria; Nicotinamide Riboside

Outcome Measures

Primary Outcomes (1)

• Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III

  The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses motor and non-motor symptoms of PD through four parts, with individual items rated on a 0-4 scale. Subscores are summed to provide a total score ranging from 0 to 260, with higher scores indicating greater disability. The primary outcome will be the MDS-UPDRS Total Score (sum of parts I, II, and III).

  From baseline to the end of treatment at 52 weeks

Secondary Outcomes (8)

• Severity of motor symptoms in PD.

  From baseline to the end of treatment at 52 weeks

• Severity of dopaminergic nigrostriatal denervation, assessed by [¹²³I]FP-CIT single photon emission CT (DaTscan)

  From baseline to the end of treatment at 52 weeks

• Severiy of non-motor symptoms in daily living in PD

  From baseline to the end of treatment at 52 weeks

• Severity of motor aspects of experiences of daily living in PD.

  From baseline to the end of treatment at 52 weeks

• Severity of non-motor symptoms of PD assessed by the Non-Motor Symptoms Assessment Scale

  From baseline to the end of treatment at 52 weeks

Other Outcomes (4)

• brain nicotinamide adenine dinucleotide (NAD) levels

  From baseline to the end of treatment at 52 weeks

• systemic nicotinamide adenine dinucleotide (NAD) metabolism

  From baseline to the end of treatment at 52 weeks

• neurofilament light-chain (NfL) levels

  From baseline to the end of treatment at 52 weeks

Study Arms (2)

Nicotinamide Riboside

EXPERIMENTAL

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

Dietary Supplement: Nicotinamide Riboside

Placebo Comparator

PLACEBO COMPARATOR

Placebo capsules, no active ingredients.

Other: Placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

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

Also known as: NR, NAD, TruNiagen

Nicotinamide Riboside

Placebo OTHER

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

Placebo Comparator

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Oslo University Hospital: collaborator
• University Hospital, Akershus: collaborator
• Ostfold Hospital Trust: collaborator
• Førde Hospital Trust: collaborator
• Helse Fonna: collaborator
• Molde Hospital: collaborator
• Bodø sykehus: collaborator
• Sorlandet Hospital HF: collaborator
• Drammen sykehus: collaborator
• University Hospital of Northern Norway, Tromsø, Norway: collaborator

Study Sites (11)

Bodø Hospital

Bodø, Nordland, Norway

Location

Arendal Hospital

Arendal, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Vestre Viken Hospital

Drammen, Norway

Location

Førde sykehus

Førde, Norway

Location

Haugesund Hospital

Haugesund, Norway

Location

Molde sjukehus

Molde, Norway

Location

Akershus university hospital

Oslo, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Østfold Hospital

Fredrikstad, Østland, Norway

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nicotinamide-beta-riboside; NAD

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Charalampos Tzoulis, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study participants and investigators are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blinded study. N = 400 participants are randomized in a 1:1 ratio to either nicotinamide riboside (500 mg x 2 per day) or placebo.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: May 6, 2020
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (11)