Skip to content

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03503331
Acronym
PiB ADC
Enrollment
160
Registered
2018-04-19
Start date
2018-04-20
Completion date
2028-10-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Detailed description

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.

Interventions

DRUG[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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Brain amyloid PET levels will be measured with the PET tracer \[C-11\]PiB in all study participants.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of pathological beta-amyloid in the brain5 yearsThe 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.

Countries

United States

Contacts

CONTACTChinara Dosse
cdosse@uabmc.edu(205) 975-7017
CONTACTEvan Hudson
evanhudson@uabmc.edu205-934-6499
PRINCIPAL_INVESTIGATORJonathan McConathy, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026