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11C-PIB PET Study in MESA at Columbia University

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ClinicalTrials.gov Identifier: NCT03981380
Recruitment Status : Enrolling by invitation
First Posted : June 10, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Wake Forest University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University

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 PIB PET.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Vascular Diseases Alzheimer Disease Atherosclerosis Drug: 11C-PIB Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis at Columbia University
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: 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).




Primary Outcome Measures :
  1. Whole Brain 11C-PIB SUVR [ Time Frame: 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current participants in MESA 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981380


Locations
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United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
José A. Luchsinger
Wake Forest University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: José Luchsinger, MD, MPH Professor of Medicine and Epidemiology

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Responsible Party: José A. Luchsinger, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03981380     History of Changes
Other Study ID Numbers: AAAS2808
R01AG058969 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be shared at the end of data collection with a mechanism supported by the National Institute on Aging

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José A. Luchsinger, Columbia University:
Alzheimer Disease
Cognitive Impairment
11C-PiB
Atherosclerosis
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Atherosclerosis
Vascular Diseases
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases