11C-PIB PET Study in MESA at Columbia University

Sponsor

José A. Luchsinger (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03981380

Collaborator

Wake Forest University (Other), National Institute on Aging (NIA) (NIH)

250

Enrollment

Location

34.9

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment Vascular Diseases Alzheimer Disease Atherosclerosis	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 Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)