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
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Baseline differences in 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.
结局指标
主要结局
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.
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.
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.)