Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Regional SUVR Value for 18F-MK-6240
研究概览
简要总结
The study employs tau positron emission tomography (PET) imaging in a well-characterized multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with cognition, differences in tau pathology across racial/ethnic groups, and the relationship between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also investigates amyloid-dependent tau spreading.
详细描述
Deposition of hyperphosphorylated tau protein is observed in several neurodegenerative diseases including Alzheimer's Disease (AD), progressive supranuclear palsy, corticobasal degeneration, chronic traumatic encephalopathy, and frontotemporal lobar degeneration. Tau is a microtubular protein and its native function is to provide structural support to neurons. Paired helical filaments composed of dysfunctional tau protein are found in several neurodegenerative diseases. In AD, the clinical progression of dementia has been shown to correlate with the amount and topographical spread of tau throughout the brain. Therefore, detecting and quantifying tau aggregate load in brain would have diagnostic and prognostic potential in clinical management of several neurological diseases. As disease modifying drugs that target tau are being developed, there is a critical need for a reliable method of detecting tau aggregates to confirm pathology in patients entering clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 35 - 85 years
- •Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking.
- •Able to participate in all scheduled evaluations and to complete all required tests and procedures
- •Considered likely to comply with the study protocol and to have a high probability of completing the study
排除标准
- •Past or present history of a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease.
- •Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
- •Unable to lie still for PET scans.
- •Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study.
- •Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug.
- •Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.).
- •Inability to have a catheter in your vein for the injection of the radioligand (dye).
- •Currently pregnant or breastfeeding.
研究组 & 干预措施
Offspring Cohort
Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period.
干预措施: 18F-MK-6240 (Drug)
Offspring Cohort
Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period.
干预措施: 18F-Florbetaben (Drug)
结局指标
主要结局
Regional SUVR Value for 18F-MK-6240
时间窗: 1 day
Regional standardized uptake value ratio (SUVR) for 18F-MK-6240 will be calculated to investigate associations with measures of memory, olfactory function, and cerebrovascular disease.
Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben
时间窗: 1 day
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.
次要结局
未报告次要终点
研究者
Adam Brickman
Associate Professor of Neuropsychology
Columbia University