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临床试验/NCT03554551
NCT03554551已完成不适用

Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Density of vesicular acetylcholine transporter

研究概览

简要总结

Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls. Furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose parasympathetic denervation in PD.

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
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinsons disease, disease duration > 4 years, Hoehn & Yahr stage 2-3

排除标准

  • Significant neurological diseases (e.g. stroke, tumor)
  • Significant psychiatric disease
  • Previous major surgery on thoracic and/or abdominal organs
  • Significant medical disease (e.g. heart- or liver failure)
  • Inflammatory bowel disease
  • Gluten intolerance
  • Magnetic Resonance (MR) contraindications (metal in body, claustrophobia)
  • Allergy to CT-contrast fluid
  • Pacemaker
  • Any current or previous cancer involving internal organs
  • Peripheral neuropathy (except Parkinsons disease related)

结局指标

主要结局

Density of vesicular acetylcholine transporter

时间窗: Day 1

Average density will be determined in each group for intestine, pancreas, suprarenal gland, heart and relevant areas of the brain. Group differences will be calculated

次要结局

  • Correlation to measurements of dysautonomia(Day 1)
  • Correlation to measurements of neuropsychological tests(Day 1)
  • Correlation to measurements of gastrointestinal denervation(Day 1)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Horsager

Principal investigator

Aarhus University Hospital

研究点 (1)

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