UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Study Overview
=================
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.

Official Title
-----------------
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: [C-11]PiB-PET/MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Brain amyloid PET levels will be measured with the PET tracer [C-11]PiB in all study participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [C-11]PiB-PET/MRI<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |