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NCT Number: NCT03503331

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Geldmacher David, MD

SUB_INVESTIGATOR

Jeffers Charlotte Denise, RPh

SUB_INVESTIGATOR

Jonathan McConathy, MD

CONTACT

[email protected]

205-996-7115

Jonathan McConathy, MD, PhD

PRINCIPAL_INVESTIGATOR

Lapi Suzanne, PhD

SUB_INVESTIGATOR

Natelson Marissa, MD

SUB_INVESTIGATOR

Roberson Erik, MD, PhD

SUB_INVESTIGATOR

About this study

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB-ADC cohort. The amount and distribution of [C-11]PiB in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from [C-11]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).
  • Negative urine or serum B-hCG test within 2 days of [C-11]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion criteria

  • Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).
  • Inability or contraindication for undergoing MRI and/or PET imaging
  • Inability to participate in the imaging studies due to severity of dementia

Treatment and study plan

[C-11]PiB-PET/MRI

Drug

All study participants will undergo brain imaging with [C-11]PiB-PET/MRI. [C-11]PiB is a PET imaging agent used primarily to measure the amount of abnormal protein (called beta-amyloid) in the brain. The investigator will also use this tracer to evaluate regional cerebral blood flow.

Primary outcomes

  1. Measurement of pathological beta-amyloid in the brain

    Time frame: 5 years

    The amount of pathological beta-amyloid in the brains of study participants will be measured with [C-11]PiB-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.

Study contacts

Contact information is provided by the study sponsor or research team.

Chinara Dosse

CONTACT

[email protected]

(205) 975-7017

Evan Hudson

CONTACT

[email protected]

205-934-6499

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: PiB ADC

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Apr 19, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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