Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease
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
- 是
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
Jacob Horsager
Principal investigator
Aarhus University Hospital
