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首页> 外文期刊>BMC Neurology >Study protocol of the DUtch PARkinson Cohort (DUPARC): a prospective, observational study of de novo Parkinson’s disease patients for the identification and validation of biomarkers for Parkinson’s disease subtypes, progression and pathophysiology
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Study protocol of the DUtch PARkinson Cohort (DUPARC): a prospective, observational study of de novo Parkinson’s disease patients for the identification and validation of biomarkers for Parkinson’s disease subtypes, progression and pathophysiology

机译:荷兰帕金森队队列(Duparc)的研究协议:De Novo Parkinson病患者鉴定和验证帕金森病亚型,进展和病理生理学生物标志物鉴定和验证的前瞻性观察研究

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Parkinson’s Disease (PD) is a heterogeneous, progressive neurodegenerative disorder which is characterized by a variety of motor and non-motor symptoms. To date, no disease modifying treatment for PD exists. Here, the study protocol of the Dutch Parkinson Cohort (DUPARC) is described. DUPARC is a longitudinal cohort study aimed at deeply phenotyping de novo PD patients who are treatment-na?ve at baseline, to discover and validate biomarkers for PD progression, subtypes and pathophysiology. DUPARC is a prospective cohort study in which 150 de novo PD subjects will be recruited through a collaborative network of PD treating neurologists in the northern part of the Netherlands (Parkinson Platform Northern Netherlands, PPNN). Participants will receive follow-up assessments after 1?year and 3?years, with the intention of an extended follow-up with 3?year intervals. Subjects are extensively characterized to primarily assess objectives within three major domains of PD: cognition, gastrointestinal function and vision. This includes brain magnetic resonance imaging (MRI); brain cholinergic PET-imaging with fluoroethoxybenzovesamicol (FEOBV-PET); brain dopaminergic PET-imaging with fluorodopa (FDOPA-PET); detailed neuropsychological assessments, covering all cognitive domains; gut microbiome composition; intestinal wall permeability; optical coherence tomography (OCT); genotyping; motor and non-motor symptoms; overall clinical status and lifestyle factors, including a dietary assessment; storage of blood and feces for additional analyses of inflammation and metabolic parameters. Since the start of the inclusion, at the end of 2017, over 100 PD subjects with a confirmed dopaminergic deficit on FDOPA-PET have been included. DUPARC is the first study to combine data within, but not limited to, the non-motor domains of cognition, gastrointestinal function and vision in PD subjects over time. As a de novo PD cohort, with treatment na?ve subjects at baseline, DUPARC provides a unique opportunity for biomarker discovery and validation without the possible confounding influences of dopaminergic medication. NCT04180865; registered retrospectively, November 28th 2019.
机译:帕金森病(PD)是一种异质,进行的神经变性障碍,其特征在于各种电机和非运动症状。迄今为止,不存在对PD进行修饰治疗的疾病。这里,描述了荷兰帕金森队队列(Duparc)的研究方案。 Duparc是一个纵向队列研究,旨在深入表型患者在基线上进行治疗 - Na'Ve的eNovo Pd患者,发现和验证PD进展,亚型和病理生理学的生物标志物。 Duparc是一项潜在的队列研究,其中将通过在荷兰北部的PD治疗神经科医生的合作网络(Parkinson平台,PPNN)招募150 de Novo PD科目。与会者将在1年和3年后收到后续评估,目的是延长随访3?年间隔。受试者被广泛的特征是主要评估PD:认知,胃肠功能和视力的三个主要结构域内的目标。这包括脑磁共振成像(MRI);脑胆碱能宠物成像用氟乙氧基异甲胺醇(Feobv-PET);脑多巴胺能宠物成像与氟德罗德(FDOPA-PET);详细的神经心理学评估,涵盖所有认知结构域;肠道微生物组成;肠壁渗透率;光学相干断层扫描(OCT);基因分型;电机和非运动症状;整体临床地位和生活方式因素,包括饮食评估;血液和粪便储存,以进行炎症和代谢参数的额外分析。由于纳入的开始,在2017年底,已包括超过100种PD受试者对FDOPA-PET上的多巴胺能缺陷的影响。 Duparc是第一研究,将数据组合在一起,但不限于PD受试者的认知,胃肠功能和视觉的非运动结构域。作为De Novo PD队列,在基线的治疗Na ve受试者,Duparc为生物标志物发现和验证提供了独特的机会,而无需多巴胺能药物可能的混淆影响。 NCT04180865;注册回顾性,2019年11月28日。

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