NCT00970229已完成1 期
Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in Subjects With Parkinson Disease, Huntington Disease, and Healthy Controls
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects
研究概览
简要总结
The underlying goal of this study is to assess [123I]MNI-420 SPECT imaging as a tool to detect A2aR density in the brain of PD and HD research participants to be compared with similarly aged healthy subjects.
详细描述
- To assess the dynamic uptake and washout of [123I]MNI-420 in brain using single photon emission computed tomography (SPECT) in Parkinson's disease (PD), Huntington's disease (HD), and similarly aged healthy subjects as a potential imaging biomarker of adenosine receptor type A2a (A2aR) in brain
- To acquire initial safety data following injection of [123I]MNI-420
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
- •Parkinson Subject Selection. Subjects who have a clinical diagnosis of PD will be recruited for this study. 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 based on UK Brain Bank Criteria
- •For females, non-child bearing potential or negative urine pregnancy test on day of [123I]MNI-420 injection.
- •Huntington Disease Subject Selection. Subjects with a diagnosis of HD will be recruited for this study. The following criteria will be met for inclusion of HD subjects in this study:
- •The participant is 18 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of symptomatic Huntington disease with genetic confirmation
- •Subject is able to provide informed consent as judged by the investigator, or assent can be obtained from the subject and informed consent provided by the appropriate legal representative or next of kin.
- •For females of child-bearing potential, a negative urine pregnancy test on day of [123I]MNI-420 injection.
- •Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. 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.
- •For females, non-child bearing potential or negative urine or blood pregnancy test on day of [123I]MNI-420 injection.
排除标准
- •Parkinson subjects will be excluded from participation for the following reasons:
- •The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Clinically significant evidence of vascular disease or alternative neurologic disorder
- •Pregnancy
- •Huntington disease 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 any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
- •Clinically significant evidence of vascular disease or alternative neurologic disorder
- •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 any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Pregnancy
- •Clinically significant evidence of vascular disease or neurologic disorder
研究组 & 干预措施
Assess [123I]MNI-420 and SPECT Imaging
Experimental
To assess [123I]MNI-420 and SPECT Imaging in PD, HD subjects and similarly aged healthy subjects.
干预措施: [123I]MNI-420 (Drug)
结局指标
主要结局
To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects
时间窗: 1 year
次要结局
未报告次要终点
研究者
David Russell, MD, PhD
Principal Investigator
Institute for Neurodegenerative Disorders
研究点 (1)
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