UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Alzheimer Disease Clinical Trial

— PiB ADC  

Official title:

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503331
• Other study ID #: IRB-300001005
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2018
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: April Riddle
• Phone: 2059346504
• Email: ariddle[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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