A Randomized Controlled Trial of Nicotinamide Riboside Supplementation in Early Parkinson's Disease: the NOPARK Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 15
- 主要终点
- Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Study participants and investigators are blinded.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Disease severity assessed by the total MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease rating Scale): sum of subsections I, II, and III
时间窗: From baseline to the end of treatment at 52 weeks
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).
次要结局
- 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)
- Change in the clinical severity of cognitive decline assessed by the Montreal Cognitive Assessment (MoCA) scale(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.(From baseline to the end of treatment at 52 weeks)
- Hoehn and Yahr stage of PD(From baseline to the end of treatment at 52 weeks)