EUCTR2010-019894-13-IT进行中（未招募）不适用
The Parkinson's Progression Markers Initiative (PPMI) - PPMI
MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH0 个研究点目标入组 600 人开始时间: 2012年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Parkinson Disease(PD)Subjects: 1.Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia. 2.A diagnosis of Parkinson disease for two years or less at Screening. 3.Hoehn and Yahr stage I or II. 4.Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit. 5.Not expected to require PD medication with at least 6 months from Baseline. 6.Male or female age 30 years or older at time of PD diagnosis. Healthy Control (HC)Subjects: 1.Male or female age 30 years or older at Screening. 2.Confirmation from imaging core that screening DAT scan is consistent with no dopamine transporter deficit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Parkinson Disease (PD) Subjects: 1.Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication. 2.Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline. 3.Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days. 4.Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 5.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7.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). Healthy Control (HC) Subjects: 1.Current or active neurological disorder. 2.First degree relative with idiopathic PD (parent, sibling, child). 3.MoCA score = 26. 4.Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 5.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7.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).
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