NCT01028209终止1 期
Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants.
研究概览
简要总结
The underlying goal of this study is to assess [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of Alzheimer Disease (AD), Parkinson Disease (PD) and Multiple Sclerosis (MS) research participants.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following criteria will be met for inclusion of AD subjects in this study:
- •The participant is 50 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- •Clinical Dementia Rating Scale score ≤
- •Modified Hachinski Ischemia Scale score of ≤
- •For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
- •The following criteria will be met for inclusion of PD subjects in this study:
- •The participant is 30 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).
- •Hoehn and Yahr ≤
- •For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
- •The following criteria will be met for inclusion of MS subjects in this study:
- •The participant is 18 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005 Revised McDonald Criteria; Polman, et al., 2005).
- •Kurtzke Expanded Disability Status Scale (EDSS) ≤ 7.
- •For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection
- •The following criteria will be met for inclusion of healthy control subjects in this study:
- •The participant is 18 years or older.
- •Written informed consent is obtained.
- •Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- •Clinical Dementia Rating score =
- •For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
排除标准
- •Alzheimer's subjects will be excluded from participation for the following reasons:
- •The subject has a history of significant cerebrovascular disease.
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
- •Parkinson's subjects will be excluded from participation for the following reasons:
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
- •MS subjects will be excluded from participation for the following reasons:
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
- •Healthy control subjects will be excluded from participation for the following reasons:
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
研究组 & 干预措施
Assess [18F] PBR06 and PET imaging
Experimental
干预措施: [18F] PBR06 (Drug)
结局指标
主要结局
To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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