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Tau PET Imaging in Atypical Dementias

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ClinicalTrials.gov Identifier: NCT03283449
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Emily Rogalski, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia With Suspected Alzheimer's Disease Drug: 18F-AV-1451 Device: PET Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau PET Imaging in Atypical Dementias
Study Start Date : February 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 1, 2023


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.
Drug: 18F-AV-1451
Other Name: AV-1451

Device: PET
PET scanner for brain imaging




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have primary progressive aphasia

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Receiving radiation clinically

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): NCT03283449


Contacts
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Contact: Christina Coventry, MS, RN 312-908-9681 christina.coventry@northwestern.edu
Contact: Emily Rogalski, Ph.D. 312-503-1155 erogalski@gmail.com

Locations
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United States, Illinois
Cognitive Neurology and Alzheimer's Disease Center - Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Christina Coventry, MS, RN    312-908-9681    christina.coventry@northwestern.edu   
Contact: Emily Rogalski, Ph.D.    312-503-1155    erogalski@gmail.com   
Principal Investigator: Emily Rogalski, Ph.D.         
Sponsors and Collaborators
Northwestern University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Emily Rogalski, Ph.D. Northwestern University

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Responsible Party: Emily Rogalski, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03283449     History of Changes
Other Study ID Numbers: STU00200893
R01AG056258 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases