Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Differences in the rate of decline of synaptic density.
研究概览
简要总结
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.
DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease
- •Less than 5 years disease duration since motor symptom onset according to the patient
- •Hoehn-Yahr stage 1 or 2 in medication ON state
- •Capacity to understand the informed consent form
排除标准
- •Neuropsychiatric diseases other than PD
- •Major internal medical diseases
- •Relevant abnormalities on MR brain
- •History of alcohol or drug abuse
- •Contraindications for MR
- •Pregnancy
- •Previous participation in other research studies involving ionizing radiation with > 1 mSv over past 12 months.
研究组 & 干预措施
PD patients
At baseline and 2-year follow-up
干预措施: 11C-UCB-J PET-CT (Other)
PD patients
At baseline and 2-year follow-up
干预措施: 18F-PE2I PET-MR (Other)
Healthy controls
At baseline and 2-year follow-up
干预措施: 11C-UCB-J PET-CT (Other)
Healthy controls
At baseline and 2-year follow-up
干预措施: 18F-PE2I PET-MR (Other)
结局指标
主要结局
Differences in the rate of decline of synaptic density.
时间窗: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences (%) in the rate of decline of synaptic density between patients and controls.
Correlations between clinical scores and synaptic density.
时间窗: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between clinical scores and synaptic density in the patient group.
Correlations between progression of the clinical scores and decline of synaptic density.
时间窗: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
Baseline differences in synaptic density.
时间窗: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline differences (%) in synaptic density between patients and controls.
次要结局
- Differences in the rate of decline of global and DAT levels.(Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.)
- Baseline differences in DAT levels.(Data analysis wel be done when all subjects have undergone the baseline evaluation.)
- Correlations between clinical scores and DAT levels.(Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.)
- Correlations between progression of the clinical scores and decline of DAT levels.(Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.)