UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [C-11]PiB-PET/MRI.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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.
Primary outcome measures
- Measurement of pathological beta-amyloid in the brain [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Alabama at Birmingham Medical Center — Birmingham
Identifiers
NCT: NCT03503331 · IRB-300001005 · 1P30AG086401-01