11C-PIB PET Study in MESA at Columbia University

NCT03981380 | Completed FDA Drug

• 2 other identifiers: AAAS2808R01AG058969
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Vascular Diseases; Alzheimer Disease; Atherosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

11C-PIB DRUG

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

Also known as: PIB

MESA study participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current participants in MESA study in New York City

You may qualify if:

• Current participants in MESA study at Columbia University
• years or older
• Fluent in English and/or Spanish.
• Able to participate in all scheduled evaluations and to complete all required tests and procedures.

You may not qualify if:

• 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)

Sponsors & Collaborators

• José A. Luchsinger: lead
• Wake Forest University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will store plasma and serum.

MeSH Terms

Conditions

Cognitive Dysfunction; Vascular Diseases; Alzheimer Disease; Atherosclerosis

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cardiovascular Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• José Luchsinger, MD, MPH

  Professor of Medicine and Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 10, 2019
• Study Start: August 1, 2020
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

US (1)