NL-OMON45667已完成不适用
The Personalized Parkinson Project - PPP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Prior to enrollment in this clinical investigation, candidates must meet ALL of the following criteria:;* Subject has Parkinson*s disease of <=5 years duration, defined as time since diagnosis made by a neurologist.
- •* Subject is an adult, at least 18 years of age.
- •* Subject can read and understand Dutch.
- •* Subject has completed the CMO-approved Informed Consent.
- •* Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection.
- •* Subject is not a current or previous employee or family member of employees of the institutions involved in the study, including Verily Life Sciences and Radboudumc.
排除标准
- •Candidates must be excluded from this study if ANY of the following criteria are met:;* Subject is pregnant or breastfeeding.
- •* Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
- •* Contraindicated for MRI, e.g. claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, and/or other medical device or other non-removable metal part incompatible with MRI.
- •* For lumbar puncture:
- •o Allergy to local anesthetic agents
- •o Medical history of compression of spinal cord, current local skin infection at the site of the lumbar puncture, developmental abnormalities in lower spine, blood coagulopathy, anticoagulant medication (Acenocoumarol, Warfarin, Dabigatran).
- •o Clinical (or previous MRI) evidence of structural cerebral abnormalities that are not compatible with the performance of a lumbar puncture such as malignancies, abscess, or obstructive hydrocephalus.
研究者
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