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Recruiting NCT03809351

UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy

Phase I Interventional Alzheimer Disease

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: [F-18]AV-1451-PET.
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 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.

Interventions

  • 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.

Primary outcome measures

  • Measurement of pathological tau deposition in the brain. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
  • 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.
  • 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

  • Meets any exclusion criteria for the UAB-ADC study.
  • 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
  • UAB — Birmingham

Identifiers

NCT: NCT03809351 · IRB-300002780 R19-006 · 1P30AG086401-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗