Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
研究概览
简要总结
This study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. Participants will have brain imaging to assess dopamine transporter density. The imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.
详细描述
The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.
On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.
Participants may be contacted to repeat these procedures every 12 to 18 months.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •22 years or older
- •A clinical diagnosis of Parkinson's disease (PD), positive family history of PD and/or potential exposure to environmental toxins
- •Normal screening laboratory studies
排除标准
- •Pregnancy
- •Psychiatric disease other than history of depression
- •Significant medical disease including abnormalities on screening
研究组 & 干预措施
[123I]ß CIT and SPECT imaging
To assess [123I]ß-CIT and SPECT imaging
干预措施: [123I]ß CIT and SPECT imaging (Drug)
结局指标
主要结局
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
时间窗: 2 yrs
次要结局
- CIT uptake measures from at-risk individuals will be compared with healthy subjects.(2 yrs)
研究者
Kenneth Marek, MD
Principal Investigator
Institute for Neurodegenerative Disorders