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临床试验/NCT03981380
NCT03981380已完成不适用

11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis at Columbia University

José A. Luchsinger1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Whole Brain 11C-PIB SUVR

研究概览

简要总结

The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.

详细描述

This is a single center PET study of 11C-PIB. Eligible participants are current participants in the MESA study in New York City, without contraindications to MRI or PET procedures. Those eligible will have one brain PET scan with 11C-PIB within 12 months of a brain MRI. Vital signs will be checked prior to injection of 11C-PIB, 10 minutes after the injection, and again at the completion of the PET scan. The primary outcome measure for amyloid will be whole brain 11C-PIB SUVR. The relation between exposure groups and amyloid in the brain will be analyzed using linear regression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current participants in MESA study at Columbia University
  • 60 years or older
  • Fluent in English and/or Spanish.
  • Able to participate in all scheduled evaluations and to complete all required tests and procedures.

排除标准

  • Active treatment for cancer
  • Any serious medical condition which would prevent long-term participation
  • Pregnancy
  • Weight >300 pounds
  • Participants previously diagnosed or adjudicated to have dementia
  • Participants unwilling to undergo cognitive testing
  • Plans to leave the community within five years
  • Language barrier (speaks other than English, Spanish, Chinese)
  • Inability to give informed consent or to obtain consent from a Legally Authorized Representative (LAR)

研究组 & 干预措施

MESA study participants

Current participants in the MESA study in New York City, 60 years or older, fluent in English or Spanish, able to participate in the brain imaging study

干预措施: 11C-PIB (Drug)

结局指标

主要结局

Whole Brain 11C-PIB SUVR

时间窗: 40 to 90 minutes post injection

Standardized uptake value ratio (SUVR) of 11C-PIB;The extent of Aβ deposition in the brain will be quantified by\[11C\]PiB uptake visualized by PET using standardized uptake volume ratio (SUVR) of 6 primary cortical areas (i.e., anterior cingulate, prefrontal cortex, lateral temporal cortex, posterior parietal cortex, precuneus cortex, and anteroventral striatum) relative to the uptake in the cerebellum

次要结局

未报告次要终点

研究者

发起方
José A. Luchsinger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

José A. Luchsinger

Associate Professor of Medicine

Columbia University

研究点 (1)

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11C-PIB PET Study in MESA at Columbia University | 临床试验