[123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images
研究概览
简要总结
The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.
详细描述
All subjects will be imaged at the Institute for Neurodegenerative Disorders.
Subjects will be evaluated sequentially with [123I]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had [123I]ß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study.
Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer.
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.
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
- 否
入选标准
- •Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) [123I] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)].
排除标准
- •Inability to sign informed consent and participate in all study procedures.
- •Mini mental status exam <
- •Pregnancy
研究组 & 干预措施
Assess [123I]B-CIT SPECT imaging
To assess[123I]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed.
干预措施: [123I]B-CIT SPECT imaging (Drug)
结局指标
主要结局
Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images
时间窗: 40 weeks
The use of SPECT to measure striatal dopamine-transporter density with the use of \[123I\]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.
次要结局
未报告次要终点
研究者
Kenneth Marek, MD
Principal Investigator
Institute for Neurodegenerative Disorders