Tau PET Imaging in the NACC Study Cohort: Modulators of MTL Subregion Structure and Function in Normal and Pathological Aging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Examine uptake of 18F-AV-1451 in the medial temporal lobe (MTL) and its relationship with high-resolution structural and functional MRI measures of MTL subregions.
研究概览
简要总结
The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). 18F-AV-1451 is a specialized radioactive PET imaging agent that is able to detect the presence of tau in the brain. In this study, the investigator will use the 18F-AV-1451 to capture images of tau in the brain. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of very early Alzheimer's disease.
详细描述
The investigator will conduct a tau PET scan in cognitively normal older adults enrolled in the National Alzheimer's Coordinating Center (NACC) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).
Study Duration: Study duration will generally be a one-day study visit, but all subjects will be followed annually as part of their participation in the NACC study.
Participants may be asked to obtain a longitudinal follow-up scan approximately 2-3 years after the baseline scan.
Study Center(s): Penn Memory Center/Alzheimer's Disease Core Center at Perelman Center for Advanced Medicine, UPHS.
Objectives: To collect Tau PET imaging in cognitively normal older adults adults and patients with Mild Cognitive Impairment (MCI), in the NACC study to determine relationship to clinical, cognitive, and other biomarker data. In particular, the investigator will examine relationship of tau PET to structural and functional measures of medial temporal lobe (MTL) subregions. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 60 years of age.
- •Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or MCI.
- •NACC longitudinal visit must be completed or scheduled to be completed within 6 months of the 18F-AV-1451 TAU PET scan.
- •A brain MRI must be performed within 12 months prior to their study scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T and/or 7 Tesla high-resolution imaging of medial temporal lobe structures.
- •An amyloid PET scan completed or scheduled within 12 months of their study scan date
- •Women must be post-menopausal or surgically sterile
排除标准
- •Any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan
- •Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
- •Have current clinically significant cardiovascular disease .Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
研究组 & 干预措施
Normal Controls and MCI
All subjects will receive 18F-AV-1451 PET scan.
干预措施: the radiotracer 18F-AV-1451 (Drug)
结局指标
主要结局
Examine uptake of 18F-AV-1451 in the medial temporal lobe (MTL) and its relationship with high-resolution structural and functional MRI measures of MTL subregions.
时间窗: 2 years.
Specific analyses will include quantitative measures of 18F-AV-1451 within the medial temporal lobe (MTL) and its relationship to volume and thickness of MTL subregions measured with high-resolution MRI.
次要结局
- Determine relationship to clinical, cognitive, and other biomarker data(2 years.)
研究者
David Wolk
Co Director of the Penn Memory Center
University of Pennsylvania