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临床试验/NCT01358474
NCT01358474已完成不适用

Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

University of Minnesota1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss

研究概览

简要总结

The purpose of this study is to determine if participants have changes in dopamine cells in their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement disorders such as essential tremor or dystonia. DaTSCAN, which is also known as 123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive iodine, it allows doctors to use a special machine called single photon emission computed tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain and help determine if there are changes in brain dopamine. It is hoped that this study will help doctors detect the presence of dopamine changes even before symptoms are present. This study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g., those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written consent prior to study by the subject or their surrogate
  • Subjects >/= 18 years and</=85 years
  • Diagnosis of Parkinson's disease, family history of Parkinson's disease, idiopathic rapid eye movement sleep behavioral disorder, age-matched controls, Gaucher's disease or carrier of Gaucher's gene mutation
  • Females using adequate methods of birth control or not of childbearing potential

排除标准

  • Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
  • Any exposure to investigational drugs within 4 weeks prior to Visit 1
  • Any exposure to radiopharmaceuticals within 4 weeks prior to Visit 1
  • Pregnancy
  • Breastfeeding
  • Severe swallowing problems
  • Known sensitivity or allergy to iodine containing products
  • Advanced liver or renal disease

结局指标

主要结局

single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss

时间窗: Visit 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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