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11C-PIB PET Study in MESA at Columbia University

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03981380
Enrollment
59
Registered
2019-06-10
Start date
2020-08-01
Completion date
2024-02-05
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Vascular Diseases, Alzheimer Disease, Atherosclerosis

Keywords

Alzheimer Disease, Cognitive Impairment, 11C-PiB, Atherosclerosis

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.

Interventions

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

Sponsors

Wake Forest University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
José A. Luchsinger
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Whole Brain 11C-PIB SUVR40 to 90 minutes post injectionStandardized 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026