Recruiting
Phase 2

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT03503331

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

[C-11]PiB-PET/MRI

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Study ID

NCT03503331

Start date

Apr 20, 2018

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

\- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).

2\. 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:

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

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [C-11]PiB-PET/MRI

All participants in this study will undergo an amyloid-PET imaging using the tracer \[C-11\]PiB with a simultaneous PET/MRI system. The \[C-11\]PiB dosage is 300-670 MBq (8 - 18 mCi) given intravenously, and the PET/MRI imaging time is approximately 60 min.

Interventions

[C-11]PiB-PET/MRI

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 outcome measure

  • Measurement of pathological beta-amyloid in the brain [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Chinara Dosse

(205) 975-7017cdosse@uabmc.edu

Evan Hudson

205-934-6499evanhudson@uabmc.edu

Locations

University of Alabama at Birmingham Medical Center

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jonathan McConathy, MD

205-996-7115jmcconathy@uabmc.edu

Principal Investigator:

Jonathan McConathy, MD, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-12.