UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Phase 2RecruitingNCT03503331

University of Alabama at Birmingham160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

160

Conditions

Alzheimer Disease

Interventions

[C-11]PiB-PET/MRIDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Central Contacts

Chinara Dosse

CONTACT

(205) 975-7017 cdosse@uabmc.edu

Evan Hudson

CONTACT

205-934-6499 evanhudson@uabmc.edu

Data from ClinicalTrials.gov

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