NCT01556100已完成2 期
Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Chang Gung Memorial Hospital0 个研究点目标入组 40 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36
研究概览
简要总结
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
详细描述
The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.
This study is expected to be completed in a period of 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 20 years to 80 years.
- •Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD
- •Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent)
- •Exclusion criteria:
- •Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
- •Alcohol or substance abuse.
- •History or presence of QTc prolongation. (>500msec)
- •History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- •Unable to stay still in the MRI or PET scanner for 30 minutes.
- •Pregnancy and breast feeding.
- •Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of > 3x the upper limit of normal
排除标准
- 未提供
研究组 & 干预措施
18F-DTBZ AV-133
Experimental
18F-DTBZ AV-133 imaging
干预措施: 18F-DTBZ AV-133 (Drug)
结局指标
主要结局
Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36
时间窗: three years
To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.
次要结局
- To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.(three years)
研究者
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