Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
研究概览
简要总结
This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.
详细描述
Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.
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
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-100
- •Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.
排除标准
- •Subjects unable to lie down without moving for 10 minutes
- •Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
- •Claustrophobic patients unable to tolerate the scans
- •Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
研究组 & 干预措施
PiB PET, FDG PET, Tau PET
干预措施: Pittsburgh Compound B (C-11 PiB) (Drug)
PiB PET, FDG PET, Tau PET
干预措施: F-18 FDG (Drug)
PiB PET, FDG PET, Tau PET
干预措施: Tau (18-F-AV-1451) (Drug)
结局指标
主要结局
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
时间窗: up to 20 years
次要结局
- To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.(up to 20 years)
- Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented.(up to 20 years)
- To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.(up to 20 years)
- To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance.(up to 20 years)
研究者
Val Lowe
Consultant - Diagnostic Radiology
Mayo Clinic