Effects of Exenatide on Motor Function and the Brain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA).
研究概览
简要总结
The purpose of this research study is to investigate how the brain and motor behavior changes Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD patients have experienced symptomatic improvement on Exenatide and literature suggests it may help slow the progression of Parkinson's. Both will be evaluated in this study.
详细描述
Participants will receive baseline testing to confirm a diagnosis of Parkinson's Disease and to determine eligibility in the research study. All of the participants in this study will receive the study drug (Exenatide). The study drug will be provided at the end of the first visit, and participants will be administered the drug once per week for the duration of the study (1 year).
During the research study the following test may occur: (1) questionnaires about quality of life and depression; (2) tests to measure strength and motor function; (3) tests to measure cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI scan of the brain; (6) structural MRI scan of the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients clinically diagnosed with Parkinson's disease (PD) through use of the UK PD brain bank diagnostic criteria
- •early stage PD patients within 5 years of diagnosis who have never taken Exenatide for any reason
- •PD patients with a Hoehn and Yahr stage less than or equal to 2 when on medication
- •patients able and willing to sign informed consent.
排除标准
- •individuals who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator)
- •individuals with a certain type of metallic clip in the body (i.e., an aneurysm clip in the brain)
- •claustrophobia
- •women who are or might be pregnant and nursing mothers. Pregnancy tests will be carried out for each female subject prior to the MRI scan.
- •psychiatric disorders or dementia
- •other neurologic and orthopedic problems that impair hand movements and walking
- •individuals actively participating in another trial of a device, drug or surgical treatment for Parkinson's disease
- •individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, will need radiological clearance to participate in this study. Specifically, individuals who report a history of metalworking will be referred to Radiology at Shands University of Florida(UF) for an orbitofrontal x-ray.
- •individuals who have sustained an eye injury involving metal will also be referred to Radiology at Shands UF for an orbitofrontal x-ray.
- •prior stroke or brain tumor
- •cognitive impairment as assessed by a Montreal Cognitive Assessment score < 23
- •individuals unwilling to comply with the study procedures
- •history of gallstones, digestion problems (such as gastroparesis), severe gastrointestinal disease, history of pancreatitis, a thyroid tumor or cancer, pancreas tumor, or kidney problems
- •severely impaired renal function with creatinine clearance less than 30 ml/min
- •hyperlipidemia defined as more than two times the upper limit of normal
- •body mass index less than 18.5
- •previous exposure to Exenatide
研究组 & 干预措施
Exenatide
This group will receive a weekly Exenatide 2mg injection for one year.
干预措施: Exenatide (Drug)
结局指标
主要结局
Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA).
时间窗: Baseline and one-year
12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.
Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen.
时间窗: Baseline and one-year
12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen.
Change in free-water accumulation in the substantia nigra
时间窗: Baseline and one-year
12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra.
Change in blood oxygen level-dependent(BOLD) signal in M1.
时间窗: Baseline and one-year
12-month study in PD to watch the effect of Exenatide on BOLD signal in M1.
次要结局
未报告次要终点