跳至主要内容
临床试验/NCT01106976
NCT01106976已完成不适用

Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2010年5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
67
试验地点
1
主要终点
AChE PET Neuroimaging

研究概览

简要总结

The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

详细描述

The project will apply positron emission tomography (PET) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with Parkinson disease. Acetylcholinesterase PET imaging was used to assess cholinergic changes over time in this study. Acetylcholinesterase PET imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase PET. Therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD.
  • Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study.
  • Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.

排除标准

  • contra-indication for magnetic resonance study
  • Pregnancy or breastfeeding

结局指标

主要结局

AChE PET Neuroimaging

时间窗: 4 yr

AChE PMP PET hydrolysis rate outcome measure. AChE \[11C\]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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