11C-PIB PET Study in MESA at Columbia University

Completed

• Conditions: Vascular Diseases; Atherosclerosis; Cognitive Impairment; Alzheimer Disease
• Interventions: Drug: 11C-PIB

• Registration Number: NCT03981380
• Lead Sponsor: José A. Luchsinger

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2020-08-01
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MESA study participants	11C-PIB	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

Primary Outcome Measures

Name	Time	Method
Whole Brain 11C-PIB SUVR	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

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States