11C-PIB PET Study in MESA at Columbia University

NCT ID: NCT03981380

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-02-05

Brief Summary

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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

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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.

Conditions

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Cognitive Impairment Vascular Diseases Alzheimer Disease Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

11C-PIB

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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PIB

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

José A. Luchsinger

OTHER

Sponsor Role lead

Responsible Party

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José A. Luchsinger

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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José Luchsinger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine and Epidemiology

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG058969

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS2808

Identifier Type: -

Identifier Source: org_study_id

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