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

April 2, 2024 updated by: Haukeland University Hospital

A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease: the NOPARK Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotinamide Riboside
nicotinamide riboside, 1000mg daily for the duration of the trial (52 weeks). Dosage form is capsules.
Dietary supplement: Nicotinamide Riboside
Nicotinamide Riboside 500mg administered two times a day. Given as capsules. Duration of the trial; 52 weeks.
Other Names:
  • NR, NAD, TruNiagen
Placebo Comparator: Placebo Comparator
Placebo capsules, no active ingredients.
Other: Placebo
Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale) subsections I-III
Time Frame: 52 weeks
The Movement Disorder Society Unified Parkinson's Disease rating Scale (MDS-UPDRS) measures multiple clinical disabilities, each on a scale of 1-4. The subscores are summed providing a total score for MDS-UPDRS. The total score ranges from 0 to 260. Higher score indicates worse outcome. Here, the total score of MDS-UPDRS sections 1-3 will be used.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the severity of nigrostriatal degeneration assessed by [¹²³I]FP-CIT single photon emission CT (DaTscan)
Time Frame: 52 weeks
[¹²³I]FP-CIT single photon emission CT (DaTscan)
52 weeks
Change in the clinical severity of non-motor symptoms assessed by the Non-Motor Symptoms Assessment Scale
Time Frame: 52 weeks
Non-Motor Symptoms Scale (NMSS) has 30 items, score range is 0-360 with higher scores indicating a worse outcome.
52 weeks
Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale
Time Frame: 52 weeks
Montreal Cognitive Assessment (MoCA), score range is 0-30 with lower scores indicating a worse outcome.
52 weeks
Change in quality of life assessed by the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire.
Time Frame: 52 weeks
Quality of Life assessment (EuroQuality of Life Five Dimensions - EQ-5D-5L).
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Charalampos Tzoulis, MD, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/2083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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