Molecular Imaging of LPS-induced Microglial Activation in Parkinson's Disease (PD). A TSPO PET-MR Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in inflammation in the brain following administration of LPS
研究概览
简要总结
It is not known what causes Parkinson's disease and what makes it worsen over time. Research conducted in the past few years has highlighted the possible role of inflammation on this process but its actual mechanisms are still obscure.
In this study, the investigators aim to gain understanding on how inflammation is increased in Parkinson's disease and what are its mechanisms, by performing two Positron Emission Tomography (PET) scans using the tracer [11C]PBR28, that takes pictures of the brain highlighting the areas of inflammation, before and after the administration of a compound called Lipopolysaccharide or LPS, that is known to cause a mild degree of inflammation. The investigators will couple this study with two venous blood draws to measure the levels of circulating molecules of inflammation.
详细描述
This is a cross-sectional study.
The study will be divided in two visits, of which, the visit 1 will take place in Exeter, and visit 2 will take place in London.
During visit 1, the participants will attend the NIHR Clinical Research Facility of Royal Devon & Exeter NHS Foundation Trust. The study doctor will explain all study procedures in a lay language and will answer all the participants' queries. After that, if they agree to participate, they will sign the informed consent. After this procedure, the study doctor will ask a few questions and assess whether the participant is suitable to be enrolled in the study. Then, the study doctor will undertake a clinical examination, and make some tests (questionnaires) to assess the presence of symptoms related to movement, thinking, memory, and behaviour. Finally, the study doctor will collect some blood and urine, for safety laboratory exams. Women of childbearing potential will also have a pregnancy test, for safety in view of the PET scans. After these procedures, the participants will be accompanied to the Mireille Gillings Neuroimaging Centre, that lies just opposite the Clinical Research Facility, and where they will perform the MRI scan. The MRI scan will collect pictures of the brain and will serve to gather information about the structure of the brain of the patients, and to exclude the concomitant presence of any lesion (incidental findings). The whole duration of the visit will be of around 3 hours, also counting the time for taking the consent and for the MRI scan.
During visit 2, the participants will attend the NIHR Imperial Clinical Research Facility and Invicro, in West London, over two consecutive days.
In the first day, the participants will attend the NIHR Imperial Clinical Research facility for a clinical visit to assess any change in medication or any side effect. Patients with Parkinson's disease will answer a few questionnaires on presence of symptoms related to PD. If more than 60 days have passed from the screening visit, participants will repeat the urine collection for safety analysis.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Parkinson's disease patients
18 patients with Parkinson's disease who will undergo clinical assessment, and PET/MR imaging of TSPO using the tracer [11C]PBR28 before and four hours after administration of LPS (1 ng/Kg)
干预措施: Lipopolysaccharide (Drug)
Parkinson's disease patients
18 patients with Parkinson's disease who will undergo clinical assessment, and PET/MR imaging of TSPO using the tracer [11C]PBR28 before and four hours after administration of LPS (1 ng/Kg)
干预措施: PET/MR with [11C]PBR28 (Radiation)
Healthy controls
6 healthy controls who will undergo clinical assessment, and PET/MR imaging of TSPO using the tracer [11C]PBR28 before and four hours after administration of LPS (1 ng/Kg)
干预措施: Lipopolysaccharide (Drug)
Healthy controls
6 healthy controls who will undergo clinical assessment, and PET/MR imaging of TSPO using the tracer [11C]PBR28 before and four hours after administration of LPS (1 ng/Kg)
干预措施: PET/MR with [11C]PBR28 (Radiation)
结局指标
主要结局
Change in inflammation in the brain following administration of LPS
时间窗: 36 months
To evaluate whether the activation of microglia following administration of LPS, as measured with PET/MR and the tracer \[11C\]PBR28, is changed in patients with Parkinson's disease compared with healthy volunteers
次要结局
- Correlation of LPS-induced increase of inflammation and cerebral perfusion(36 months)
- Correlation of LPS-induced increase of inflammation and resting state functional MRI (rs fMRI)(36 months)
- Safety of LPS administration in Parkinson's disease patients(36 months)