UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Measurement of pathological beta-amyloid in the brain
研究概览
简要总结
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study.
详细描述
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB-ADC cohort. The amount and distribution of [C-11]PiB in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from [C-11]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).
- •2. Negative urine or serum B-hCG test within 2 days of [C-11]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
排除标准
- •Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).
- •Inability or contraindication for undergoing MRI and/or PET imaging
- •Inability to participate in the imaging studies due to severity of dementia
研究组 & 干预措施
[C-11]PiB-PET/MRI
All participants in this study will undergo an amyloid-PET imaging using the tracer [C-11]PiB with a simultaneous PET/MRI system. The [C-11]PiB dosage is 300-670 MBq (8 - 18 mCi) given intravenously, and the PET/MRI imaging time is approximately 60 min.
干预措施: [C-11]PiB-PET/MRI (Drug)
结局指标
主要结局
Measurement of pathological beta-amyloid in the brain
时间窗: 5 years
The amount of pathological beta-amyloid in the brains of study participants will be measured with \[C-11\]PiB-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.
次要结局
未报告次要终点
研究者
Deepak Prabataram Kalbi
Assistant Professor
University of Alabama at Birmingham