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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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Locations


RECRUITING

United States, alabama

University of Alabama at Birmingham Medical Center

Birmingham, alabama, United States, 35294

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