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CompletedNCT03283449Updated Apr 6, 2025

Tau PET Imaging in Atypical Dementias

A Phase 1 interventional study of 18F-AV-1451 and PET in Primary Progressive Aphasia With Suspected Alzheimer's Disease, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by University of Chicago · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
20 Years to 100 Years
Sex
All
01

Study summary

The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and to systematically document the extent and location of tau pathology in PPA patients in vivo using the same techniques.

02

Conditions studied

03

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must have primary progressive aphasia

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Receiving radiation clinically
04

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    AV-1451 Recipients

    Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.

    Drug: 18F-AV-1451 · Device: PET

Interventions

  • Drug18F-AV-1451

    Also known as: AV-1451

  • DevicePET

    PET scanner for brain imaging

05

What researchers measure

Primary outcomes

  1. Tau levels in PPA participants

    Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.

    Time frame: 2 years

06

Study locations

1 site
  • University of Chicago - American School Building
    Chicago, Illinois 60637, United States
07

Registry details

Key details

Study ID
NCT03283449
Lead sponsor
University of Chicago
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Feb 2016
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Apr 6, 2025

Study contacts

Emily Rogalski, Ph.D.
principal investigator · University of Chicago
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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