NCT03587649已完成1 期
Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Invicro
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
研究概览
简要总结
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.
详细描述
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.The specific objectives are:
- Examine [18F]MNI-1126 as a tool to assess synaptic density loss.
- To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
- To measure blood metabolites of [18F]MNI-1126 and perform kinetic modeling to assess its ability to measure synaptic density loss in the brain using the tracer plasma concentration or a reference region as indirect input.
- To acquire safety data following injection of [18F]MNI-1126.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
[18F]MNI-1126
Experimental
To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
干预措施: [18F]MNI-1126 (Drug)
结局指标
主要结局
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
时间窗: 1 year
Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-1126.
次要结局
未报告次要终点
研究者
研究点 (1)
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