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Completed

NCT Number: NCT03981380

11C-PIB PET Study in MESA at Columbia University

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

11C-PiB

Drug

Participants will be injected with an intravenous bolus of up to 5-15mCi (370 MBq) (+/-10%) of [11C]PiB (over 5-10 seconds).

Other names: PIB

Primary outcomes

  1. Whole Brain 11C-PIB SUVR

    Time frame: 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

Sponsors and collaborators

Lead sponsor

José A. Luchsinger

Other

Collaborators

  • National Institute on Aging (NIA)
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2019
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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