UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

NCT03503331 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB-3000010051P30AG086401-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Measurement of pathological beta-amyloid in the brain

  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.

  5 years

Study Arms (1)

[C-11]PiB-PET/MRI

EXPERIMENTAL

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.

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

Interventions

[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.

[C-11]PiB-PET/MRI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• Inability or contraindication for undergoing MRI and/or PET imaging
• Inability to participate in the imaging studies due to severity of dementia

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jonathan McConathy, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinara Dosse

CONTACT

(205) 975-7017; cdosse@uabmc.edu

Evan Hudson

CONTACT

205-934-6499; evanhudson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: April 19, 2018
• Study Start: April 20, 2018
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)