11C-PIB PET Study in MESA at Columbia University

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03981380
• Other study ID #: AAAS2808
• Secondary ID: R01AG058969
• Status: Enrolling by invitation
• Start date: August 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Atherosclerosis
• Cognitive Dysfunction
• Cognitive Impairment
• Vascular Diseases

Intervention

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).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
José A. Luchsinger	National Institute on Aging (NIA), Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Brain 11C-PIB SUVR	Standardized uptake value ratio (SUVR) of 11C-PIB;The extent of Aß 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