Phase II Study of 18F-DTBZ: The Differential Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality for drug safety assessment
研究概览
简要总结
The primary objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality. Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease severity.
详细描述
25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders and 50~80 years old.
- •Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures
- •Healthy male or female subjects with no evidence of significant neurologic impairment by history.
- •Seventy-five PD subjects will be divided as three subgroups according to the severity of disease: mild (Modified Hoehn and Yahr stage 1 to 2), moderate (Modified Hoehn and Yahr stage 2.5 to 3), and advanced (Modified Hoehn and Yahr stage 4 to 5).
- •All the PD subjects should be fulfilled the UK Parkinson's Disease Society Brain Bank criteria of "possible" or "probable" PD. The age of disease onset should be older than 50 years.
排除标准
- •Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
- •Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- •History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- •History or presence of QTc prolongation.
- •History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- •Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
- •Patients who have the evidence of secondary
研究组 & 干预措施
18F-DTBZ for Parkinson's Disease
25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
干预措施: 18F-DTBZ (Drug)
结局指标
主要结局
To evaluate the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality for drug safety assessment
时间窗: 2 year
To evaluate the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD and normality. During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging
次要结局
- To analyze the correlation between the regionally reduced 18F-DTBZ binding and the severity of disease of PD.(1 years)
研究者
NJI90OKM
Professor
Chang Gung Memorial Hospital