- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283449
Tau PET Imaging in Atypical Dementias
April 3, 2025 updated by: University of Chicago
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago - American School Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must have primary progressive aphasia
Exclusion Criteria:
- Pregnancy
- Breastfeeding
- Receiving radiation clinically
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Other Names:
PET scanner for brain imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tau levels in PPA participants
Time Frame: 2 years
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Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Rogalski, Ph.D., University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
February 28, 2025
Study Completion (Actual)
February 28, 2025
Study Registration Dates
First Submitted
May 16, 2016
First Submitted That Met QC Criteria
September 13, 2017
First Posted (Actual)
September 14, 2017
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Metabolic Diseases
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Communication Disorders
- Language Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Alzheimer Disease
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- IRB23-1338
- R01AG056258 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Aphasia With Suspected Alzheimer's Disease
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Maya HenryNational Institute on Aging (NIA)RecruitingLogopenic Variant Primary Progressive Aphasia | Progressive Aphasia | Logopenic Progressive Aphasia (LPA) | Primary Progressive Aphasia(PPA) | Logopenic Variant of Primary Progressive Aphasia (LPA) | Progressive Aphasia in Alzheimer's DiseaseUnited States
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University of Texas at AustinThe Association for Frontotemporal DegenerationRecruitingDementia | Alzheimer Disease | Primary Progressive Aphasia | Aphasia | Progressive Aphasia | Progressive Aphasia in Alzheimer's DiseaseUnited States
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Maya HenryNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingSemantic Dementia | Logopenic Progressive Aphasia | Nonfluent Aphasia, Progressive | Logopenic Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive Aphasia (svPPA) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Progressive Aphasia | Logopenic Progressive Aphasia... and other conditionsUnited States
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
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University of ChicagoNorthwestern UniversityCompleted
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University College, LondonCompletedAlzheimer Disease | Frontotemporal Dementia | Primary Progressive AphasiaUnited Kingdom
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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Hospital San Carlos, MadridCompletedAlzheimer Disease | Frontotemporal Dementia | Primary Progressive AphasiaSpain
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University of ChicagoCompletedDementia | Alzheimer Disease | Primary Progressive AphasiaUnited States
Clinical Trials on 18F-AV-1451
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Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedTauopathies | Frontotemporal Dementia (FTD) | Frontotemporal Lobar Degeneration (FTLD)United States
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University of Southern CaliforniaAvid Radiopharmaceuticals; Alzheimer's Therapeutic Research Institute; Alzheimer...CompletedCognition DisordersUnited States
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer DiseaseUnited States
-
University of PennsylvaniaNational Institutes of Health (NIH); National Institute on Aging (NIA)Active, not recruiting
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University of ZurichAvid Radiopharmaceuticals; Swiss Federal Institute of TechnologyActive, not recruitingHealthy | Neurocognitive Disorders | Alzheimer Disease | Mild Cognitive ImpairmentSwitzerland
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Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | HIVUnited States
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Tammie L. S. Benzinger, MD, PhDRecruiting
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Washington University School of MedicineEnrolling by invitationAlzheimer DiseaseUnited States
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Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | Progressive Posterior Cortical Dysfunction (PPCD)United States
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Avid RadiopharmaceuticalsWithdrawn