Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 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 compare the sensitivity of SV2A PET and volumetric MRI to detect longitudinal striatal changes in premanifest HD.
DESIGN: The investigators will include late premanifest HD mutations carriers and matched healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 18F-SynVesT-1 PET and volumetric MRI 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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-75 years inclusive.
- •Capacity to understand the informed consent form.
- •HD mutation carriers:
- •HTT (CAG)n ≥ 40
- •HD-ISS < 2
- •CAP100 score > 70
排除标准
- •neuropsychiatric diseases (other than HD for HD mutation carriers)
- •major internal medical diseases
- •white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- •history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
- •contraindications for MR
- •pregnancy
- •previous participation in other research studies involving ionizing radiation with more than 1 mSv in the previous 12 months.
研究组 & 干预措施
Premanifest HD
At baseline and 2-year follow-up
干预措施: Diagnostic Test: 18F-SynVesT-1 PET (Diagnostic Test)
Premanifest HD
At baseline and 2-year follow-up
干预措施: Volumetric MRI (Diagnostic Test)
Healthy controls
At baseline and 2-year follow-up
干预措施: Diagnostic Test: 18F-SynVesT-1 PET (Diagnostic Test)
Healthy controls
At baseline and 2-year follow-up
干预措施: Volumetric MRI (Diagnostic Test)
结局指标
主要结局
Differences in the rate of decline of synaptic density.
时间窗: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of (regional) synaptic density between patients and controls; Sensitivity to change for synaptic density.
Differences in the rate of decline of volumetric MRI.
时间窗: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of (regional) brain volumes between patients and controls; Sensitivity to change for (regional) brain volumes.
Baseline differences in synaptic density.
时间窗: Data analysis will be done when all subjects have undergone the baseline evaluation.
Baseline differences in (regional) synaptic density between premanifest HD and controls.
Baseline differences in brain volume.
时间窗: Data analysis will be done when all subjects have undergone the baseline evaluation.
Baseline differences in (regional) brain volume between premanifest HD and controls.
次要结局
- Baseline correlations between clinical scores and regional synaptic density or brain volume.(Data analysis will be done when all subjects have undergone the baseline evaluation.)
- Correlations between progression of the clinical scores and decline of synaptic density or brain volume.(Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.)