11C-PIB PET Study in MESA at Columbia University

11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vascular Diseases; Atherosclerosis; Cognitive Impairment; Alzheimer Disease
• Intervention / Treatment: Drug: 11C-PIB

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Current participants in MESA study in New York City

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 11C-PIB; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Brain 11C-PIB SUVR	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	40 to 90 minutes post injection

Collaborators and Investigators

• Sponsor: José A. Luchsinger
• Collaborators: National Institute on Aging (NIA); Wake Forest University
• Investigators: Principal Investigator: José Luchsinger, MD, MPH, Professor of Medicine and Epidemiology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atherosclerosis; Cognitive Impairment; Alzheimer Disease; 11C-PiB
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Vascular Diseases; Alzheimer Disease; Cognitive Dysfunction; Atherosclerosis
• Other Study ID Numbers: AAAS2808; R01AG058969 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) may be shared at the end of data collection with a mechanism supported by the National Institute on Aging

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No