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UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy (AV1451 ADC)

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ClinicalTrials.gov Identifier: NCT03809351
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer Disease Drug: [F-18]AV-1451-PET Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : July 8, 2022
Estimated Study Completion Date : July 8, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of pathological tau deposition in the brain. [ Time Frame: 5 years ]
    The amount and regional distribution of pathological tau in the brains of study participants will be measured with [F-18]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809351


Contacts
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Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle, RT 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35233
Contact: April Riddle    205-934-6504    ariddle@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
More Information
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Responsible Party: Jonathan E McConathy, Director, Division of Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03809351    
Other Study ID Numbers: R19-006
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders