[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Distribution volume of [11C]donepezil in internal organs
研究概览
简要总结
AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.
MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.
PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-80 years
排除标准
- •dementia,
- •psychiatric diseases,
- •serious medical illness including any type of previous cancer
- •any drug with known interaction with the autonomic nervous system
- •metal in the body (because of MRI scan)
- •pregnancy or breast feeding (because of radiation due to PET/CT)
- •known diseases of the salivary glands, stomach, intestines.
- •Prior major surgery to salivary glands, esophagus, stomach.
结局指标
主要结局
Distribution volume of [11C]donepezil in internal organs
时间窗: The distribution volume of [11C]donepezil is measured at "Day 1" by PET/CT scanning each participant. The data analysis is done when all participants have completed the study.
Our primary endpoint is the distribution volume of \[11C\]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls.
次要结局
未报告次要终点
研究者
Per Borghammer
MD, ph.d.,DMSci
Aarhus University Hospital