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临床试验/NCT02138682
NCT02138682Unknown不适用

Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue

Wisconsin Institute for Neurologic and Sleep Disorders S.C.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Consistency Between Diagnostic Procedures

研究概览

简要总结

This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • aged 75 or older
  • sporadic late onset Parkinson disease or one of its variants
  • registered in tissue donation program

排除标准

  • aged less than 75 years old
  • mental status preventing neuroimaging or transportation to site
  • inability to remain "relatively steady" during the scanning procedure

研究组 & 干预措施

l-123 Ioflupane

Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process.

干预措施: l-123 Ioflupane (Drug)

结局指标

主要结局

Consistency Between Diagnostic Procedures

时间窗: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.

Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.

次要结局

未报告次要终点

研究者

发起方
Wisconsin Institute for Neurologic and Sleep Disorders S.C.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Paul Nausieda

Medical Director

Wisconsin Institute for Neurologic and Sleep Disorders S.C.

研究点 (2)

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