Alzheimer's Disease Research Center PET Component
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 18F-FBB Standardized Uptake Value Ratio
研究概览
简要总结
The purpose of this study is to further engage and characterize Alzheimer's Disease Research Center (ADRC) participants through additional research opportunities, particularly PET imaging. Amyloid and Tau PET imaging will be collected in 24 participants per year, for a total of 120 participants over five years.
All participants will be followed longitudinally, including through potential transitions from normal aging to mild cognitive impairment (MCI) and Alzheimer's disease and related dementias (ADRD).
详细描述
This study is a PET imaging component of the broader Alzheimer's Disease Research Center (ADRC) Clinical Core being conducted at Columbia University Irving Medical Center and is designed to further characterize ADRC participants through amyloid and tau PET imaging. The PET component supports the broader ADRC goals of maintaining a well-characterized, diverse longitudinal cohort across the spectrum of normal aging, mild cognitive impairment (MCI), and Alzheimer's disease and related dementias (ADRD), and facilitating collaborative research on cognitive aging and ADRD.
Participants in this study must first be enrolled in the parent ADRC protocol. Individuals may be approached for participation in the PET component at the time of ADRC enrollment or may be contacted after enrollment to determine their interest in participating.
Participants will complete up to three outpatient visits over a 12-month period. Study procedures include informed consent, Amyloid PET, and Tau PET imaging of the brain. Depending on scheduling and eligibility, informed consent and PET imaging may occur on the same day.
PET imaging data collected through this study will complement the longitudinal clinical and cognitive characterization performed under the parent ADRC protocol. Because ADRC participants are followed longitudinally, PET imaging may help characterize participants across the spectrum of cognitive aging, including potential transitions from normal cognition to MCI and ADRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Enrolled in the Alzheimer's Disease Resource Center (ADRC)
- •With or without memory problems or impairment
- •Able to participate in all scheduled evaluations and to complete all required tests and procedures in either English or Spanish.
- •In the opinion of the PI, the participant must be considered likely to comply with the study protocol and to have a high probability of completing the study.
排除标准
- •Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.)
- •Pregnant and/or breastfeeding
- •In the opinion of the PI, the subject has been determined unlikely to complete all procedures.
研究组 & 干预措施
Cognitive impairment
Participants with Alzheimer's disease and related disorders, including but not limited to: Frontotemporal dementia, Lewy Body dementia, Creutzfeldt-Jakob disease, other dementias, and subjective or objective features of mild cognitive change.
干预措施: 18F-MK6240 (Drug)
Cognitive impairment
Participants with Alzheimer's disease and related disorders, including but not limited to: Frontotemporal dementia, Lewy Body dementia, Creutzfeldt-Jakob disease, other dementias, and subjective or objective features of mild cognitive change.
干预措施: 18F-Florbetaben (FBB) (Drug)
No cognitive impairment
Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging.
干预措施: 18F-MK6240 (Drug)
No cognitive impairment
Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging.
干预措施: 18F-Florbetaben (FBB) (Drug)
结局指标
主要结局
18F-FBB Standardized Uptake Value Ratio
时间窗: Up to 12 months
The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-FBB PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
18F-MK6240 Standardized Uptake Value Ratio
时间窗: Up to 12 months
The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
次要结局
未报告次要终点
研究者
Patrick Lao
Assistant Professor of Neurological Sciences (in Neurology and in the Gertrude H. Sergievsky Center)
Columbia University