Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease Compared to Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Invicro
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects.
研究概览
简要总结
The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
详细描述
The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
- To measure the dynamic uptake and washout of [18F]MK-6240 in brain using positron emission tomography (PET) in patients with Alzheimer's disease and healthy volunteers.
- To measure blood metabolites of [18F]MK-6240 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input.
- To obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease and healthy volunteers (Cohort 1).
- To acquire safety data following injection of [18F]MK-6240.
- To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects.
- To evaluate the correlation between the longitudinal change in tau burden and change in clinical, MRI and CSF biomarker measures in AD subjects and in similarly-aged HV subjects.
- To further explore the relationship between tracer metabolism and smoking (Cohort 3).
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 80 Years（Adult, Older 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-946
To evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
干预措施: [18F] MNI-946 (Drug)
[18F]MNI-946
To evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
干预措施: [18F]Florbetapir (Drug)
结局指标
主要结局
To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects.
时间窗: 1 year
Tracer uptake will be evaluated in regions of interest for analysis of regional \[18F\]MK-6240 binding/uptake and expressed in SUV by using established methods for normalization for 12 AD and 3 HV subjects in Cohort 1, 8 AD and 2 HV subjects in Cohort 2, and 3 AD and 3 HV subjects in Cohort 3. Target regions of interest in the standard volume of interest (VOI) template, will be used for tracer uptake quantitation of potentially increased binding to tau pathology will correspond in particular to the cortical regions of the brain. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MK-6240. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-946.
次要结局
未报告次要终点