NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PDRP changes from NR use
研究概览
简要总结
- Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET).
- Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
- Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.
详细描述
Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All participants and investigators will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with PD
- •Drug naïve with respect to dopaminergic treatment
- •Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD
排除标准
- •[¹²³I]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.
- •Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.
- •Dementia or other neurological disorder at baseline visit
- •Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
研究组 & 干预措施
Placebo Group
Participant receiving Placebo BIDfor 30 days
干预措施: Placebo (Other)
NR Group
Participants receiving Nicotinamide Riboside capsules, 500mg BI'D for 30 days
干预措施: Nicotinamide Riboside (Dietary Supplement)
结局指标
主要结局
PDRP changes from NR use
时间窗: 4 weeks
The primary outcome will be the between-group difference in Parkinson's disease related pattern (PDRP) measured by FDG-PET comparing baseline and 3-4 week follow-up measurement.
次要结局
- Motoric change of symptoms from NR use(4 weeks)