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临床试验/NCT00096720
NCT00096720已完成2 期

Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's

Institute for Neurodegenerative Disorders26 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2004年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
112
试验地点
26
主要终点
Change in outcomes from scan 1 to scan 2

研究概览

简要总结

Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

详细描述

Brain imaging will be conducted three times during this study. Study participants will travel to IND for [123I]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for [123I]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final [123I]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of [123I]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 years or older at time of Parkinson Disease (PD) diagnosis
  • clinical diagnosis of PD of equal to or less than 7.5 years
  • Normal laboratory screening

排除标准

  • Participant is pregnant
  • Participant has atypical or drug induced PD
  • Participant has significant dementia

结局指标

主要结局

Change in outcomes from scan 1 to scan 2

次要结局

  • Change in outcomes from scan 2 to scan 3

研究者

申办方类型
Other

研究点 (26)

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