Longitudinal Evaluation of [18-F]MK-6240 as a Novel Tau PET Radiotracer in Patients With Alzheimer's Disease Dementia or Mild Cognitive Impairment Compared to Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
研究概览
简要总结
This is a longitudinal, observational study evaluating the imaging characteristics of the tau PET radioligand [18F]MK-6240 in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and Healthy Volunteer (HV) subjects. Up to 42 subjects, including approximately 28 MCI/mild AD subjects, up to 5 moderate AD subjects, and 9 similarly aged HV subjects will be consented and screened. Imaging procedures include [11C]PiB to evaluate amyloid deposition, [18F]MK-6240 PET, and structural MRI. All subjects complete an evaluable baseline [18F]MK-6240 PET scan, as well as scans at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 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
All Subjects
All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline.
If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
干预措施: All Subjects (Drug)
结局指标
主要结局
Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
时间窗: Baseline to 12 months
Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia.
次要结局
- Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Mini-Mental Status Exam (MMSE)(Baseline to 12 months)
- Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake(Baseline to 6 months)
- The Correlation Between the Change in [18F]MK-6240 Uptake and the Change in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Using Items 1-11(Baseline to 12 months)
- Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Clinical Dementia Rating Scale (CDR).(Baseline to 12 months)