JPRN-UMIN000017377已完成1 期
A Phase I /II Study of Intra-putaminal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase in Subjects with Parkinson's Disease - AADC Gene Therapy for Parkinson's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
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
- 35years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients who is suspected secondary/atypical parkinsonism . 2.Patients with history of 3 hours or more of intensive or violent dyskinesias in the past 6 months. 3.Patients with previous the stereotaxy for Parkinson's disease. 4.MMSE<_20 or patient with a diagnosis of dementia in the neuropsychological evaluation. 5.Patients with medical history of Hallucination, Delusion, schizophrenia or affective disorder within 6 months of informed consent. 6.Patients with history of significant cardiovascular disease including cerebrovascular accident. 7.Malignant neoplasm in the brain, clinically significant neurological disease. 8.History of other malignancy, with the exception of treated carcinoma cutaneum, within 5 years. 9.Uncontrolled hypertension. 10.Coagulopathy or need for anticoagulant therapy. 11.Clinically significant immune dysfunction. 12.GDS short scale>_10 points, or if on antidepressant, the score>_5 points. 13.On MAO-A inhibitors, or antipsychotic medications. 14.Unable to scan MRI. 15.Cases without abnormal finding in FMT-PET. 16.Premenopausal female or male who desire impregnating a female. 17.Past medical history of convulsive seizure within 3 years or receiving antiepileptic drug or patients with epileptic aberrance in the electroencephalography. 18.Past medical history of serious drug allergy. 19.Patients who have participated in other clinical trial within 6 months. 20.Patients who meet any of the following criteria: a)Serious renal disorder b)Serious hepatic disorder c)Serious diabetes 21.Any other patients judged by investigators to be inappropriate for the subject of this study.
研究者
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