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NCT03503331 | RECRUITING | Alzheimer Disease

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Jonathan E McConathy

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.

Condition or disease

Alzheimer Disease

Intervention/treatment

[C-11]PiB-PET/MRI

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Actual Study Start Date : 2018-04-20
Estimated Primary Completion Date : 2026-04-01
Estimated Study Completion Date : 2026-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
  • 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
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

Location Details

NCT03503331

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Alabama

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States, 35294