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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
410
Nicotinamide Riboside 500mg administered two times a day. Given as capsules. Duration of the trial; 52 weeks.
Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 52 weeks.
Bodø Hospital
Bodø, Nordland, Norway
Arendal Hospital
Arendal, Norway
Haukeland University Hospital
Bergen, Norway
Vestre Viken Hospital
Drammen, Norway
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).
Time frame: From baseline to the end of treatment at 52 weeks
Severity of motor symptoms in PD.
Change from baseline in the MDS-UPDRS Part III in the ON-medication state.
Time frame: 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)
Change from baseline in the mean striatal binding ratio (SBR) of the putamen, bilaterally, as measured \[¹²³I\]FP-CIT Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT, DaTscan).
Time frame: From baseline to the end of treatment at 52 weeks
Severiy of non-motor symptoms in daily living in PD
Change from baseline in the MDS-UPDRS Part I in the ON-medication state
Time frame: From baseline to the end of treatment at 52 weeks
Severity of motor aspects of experiences of daily living in PD.
Change from baseline in the MDS-UPDRS Part II
Time frame: 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
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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
...and 1 more locations
Change from baseline in the NMSS Score in the ON-medication state. Non-Motor Symptoms Scale (NMSS) has 30 items, score range is 0-360 with higher scores indicating a worse outcome.
Time frame: From baseline to the end of treatment at 52 weeks
Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale
Montreal Cognitive Assessment (MoCA), score range is 0-30 with lower scores indicating a worse outcome.
Time frame: From baseline to the end of treatment at 52 weeks
Change in quality of life assessed by the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire.
Quality of Life assessment (EuroQuality of Life Five Dimensions - EQ-5D-5L).
Time frame: From baseline to the end of treatment at 52 weeks
Hoehn and Yahr stage of PD
Hoehn and Yahr scale distinguishes between five stages in PD: Stage 1: Unilateral disease; Stage 2: Bilateral disease without impairment of balance; Stage 3: Bilateral disease with postural instability but physically independent; Stage 4: Severe disability; still able to walk or stand unassisted; Stage 5: Confinement to bed or wheelchair unless aided.
Time frame: From baseline to the end of treatment at 52 weeks