JPRN-UMIN000016755尚未招募未知
Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI) - Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Executive office of J-PPMI, National Center Hospital, National Center of Neurology and Psychiatry0 个研究点目标入组 200 人开始时间: 2015年3月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional,observational
入排标准
- 年龄范围
- 60years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Current or active clinically significant neurological disorder (in the opinion of the Investigator). 2)GDS score greater than or equal to 10 (GDS score of 5-9 requires Investigator discretion to enter study). 3)STAI Form Y-1 greater than or equal to 65 requires Investigator discretion to enter study(STAI Form Y-1 score of 55-64 requires Investigator discretion to enter study). 4)A clinical diagnosis of dementia as determined by the investigator. 5)A clinical diagnosis of Parkinson's disease at the Screening visit as determined by the Investigator. 6)Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 7)Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 8)Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 9)Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 10)Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 11)Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
研究者
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