Purpose

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 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 tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
  2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
  3. Negative urine or serum hCG test within 2 days of [F-18]AV-1451 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.
  2. Inability or contraindication for undergoing MRI and/or PET imaging
  3. Inability to participate in the imaging studies due to severity of dementia

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
[F-18]AV-1451-PET/MRI
All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.
  • Drug: [F-18]AV-1451-PET
    All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.

Recruiting Locations

UAB
Birmingham, Alabama 35233
Contact:
April Riddle
205-934-6504
ariddle@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.