NL-OMON44519已完成不适用
In vivo imaging of neuroinflammation in Parkinson's disease: A first in human purinergic P2X7 receptor PET study <br> - P2X7R-PD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •For healthy control subjects:
- •- Subject is between 45 and 80 years (male/female).
- •- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests.
- •- No clinical evidence of a movement disorder as evidenced by careful neurological examination by a neurologist or an MD instructed by a movement disorder specialist.;For Parkinson's patients:
- •- Subject is between 45 and 80 years (male/female)
- •- Subject has a clinical diagnosis of Idiopathic Parkinson*s Disease (IPD) according to UK PD brain bank criteria, with at least 2 of the cardinal signs of the disease: resting tremor, bradykinesia or rigidity
- •- Subject has a modified Hoehn and Yahr stage * 3
排除标准
- •- Subject has parkinsonism not caused by IPD (e.g. drug-induced, metabolic disorders, encephalitis, vascular PD, atypical PD)
- •- Subject has a history of another major neurological disorder or history of significant brain lesion (e.g. tumor, stroke)
- •- Subject has significant structural brain lesions on T1 or T2 MRI, unrelated to IPD.
- •- Subject has a history of any major disease that may interfere with radiotracer investigations (especially liver and kidney disease, or uncontrolled diabetes).
- •- Subject chronically uses anti-inflammatory medication (steroids, non-steroidal anti-inflammatory drugs (NSAIDs), aspirine, paracetamol,...)
- •- Previously subject has had exposure to ionizing radiation (> 11 mSv) in other research studies within the last 12 months.
- •- Inability to undergo PET and MRI scans (eg: metal objects in or around the body, claustrophobia or cannot tolerate confinement during PET or MR scanning procedures, unable to lie sufficiently still in the scanner for 90 minutes, or has tremor with significant head movements)
- •- Subject has had surgery, significant blood loss (> 500 ml), donated blood or participated in another clinical trial using investigational drug(s) within 30 days prior to the imaging day.
- •- History of alcohol and/or drug abuse
- •- Subject has a known allergy to lidocaine (which may be used as a local anesthetic for the placement of the arterial catheter).
- •- Subjects has an allergy including, but not limited to, hay fever, dust mite allergy and allergies to cats or dogs.
- •- Subjects has asthma ;Additionally for healthy controls: Subject has an elevated likelihood for hereditary Parkinson*s disease as assessed by family history
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