- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283449
Tau PET Imaging in Atypical Dementias
March 19, 2024 updated by: Emily Rogalski, Northwestern University
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
Recruiting
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 Contact
- Name: Seyi Adeolu
- Phone Number: 312-503-2398
- Email: PPA.Research@northwestern.edu
Study Contact Backup
- Name: Emily Rogalski, Ph.D.
- Phone Number: 312-503-1155
- Email: erogalski@gmail.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Cognitive Neurology and Alzheimer's Disease Center - Northwestern University
-
Contact:
- Seyi Adeolu
- Phone Number: 312-503-2398
- Email: PPA.Research@northwestern.edu
-
Contact:
- Emily Rogalski, Ph.D.
- Phone Number: 312-503-1155
- Email: erogalski@gmail.com
-
Principal Investigator:
- Emily Rogalski, Ph.D.
-
-
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 |
---|---|
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.
|
Other Names:
PET scanner for brain imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tau levels in PPA participants
Time Frame: 2 years
|
Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.
|
2 years
|
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., Northwestern University
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 (Estimated)
March 30, 2024
Study Completion (Estimated)
March 30, 2024
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)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Alzheimer Disease
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- STU00200893
- 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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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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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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Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
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Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
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Northwestern UniversityCompleted
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University College, LondonCompletedAlzheimer Disease | Frontotemporal Dementia | Primary Progressive AphasiaUnited Kingdom
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Centre integre universitaire de sante et de services...CompletedNeurocognitive Disorders | Alzheimer Disease | Primary Progressive AphasiaCanada
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Hospital San Carlos, MadridActive, not recruitingAlzheimer Disease | Frontotemporal Dementia | Primary Progressive AphasiaSpain
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Northwestern UniversityCompletedDementia | 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
-
University of PennsylvaniaNational Institutes of Health (NIH); National Institute on Aging (NIA)Recruiting
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer DiseaseUnited States
-
Tammie L. S. Benzinger, MD, PhDWithdrawn
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University of PennsylvaniaCompletedLogopenic Progressive Aphasia | Posterior Cortical Atrophy (PCA) | Alzheimer's Disease, Early OnsetUnited States
-
Avid RadiopharmaceuticalsCompleted
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Tammie L. S. Benzinger, MD, PhDRecruiting
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Washington University School of MedicineEnrolling by invitationAlzheimer DiseaseUnited States
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | Progressive Posterior Cortical Dysfunction (PPCD)United States