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Flortaucipir PET Imaging in Subjects With FTD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03040713
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE April 11, 2017
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
18F-AV-1451 tracer uptake measured by regional SUVr [ Time Frame: 75 minutes post dose administration ]
To estimate SUVr (Standard Uptake Value Ratio) in FTD subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03040713 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Flortaucipir PET Imaging in Subjects With FTD
Official Title  ICMJE 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
Brief Summary This study is designed to assess the usefulness of 18F-AV-1451 in Positron Emission Tomography imaging for subjects diagnosed with Frontotemporal Dementia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Frontotemporal Dementia
Intervention  ICMJE
  • Drug: 18F-AV-1451
    Subjects will receive single IV administration of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
    Other Names:
    • Flortaucipir F18
    • [F-18]T807
  • Drug: 18F-AV-45
    Subjects with no qualifying amyloid scan within three years will receive single IV administration of 370 MBq (10 mCi) of 18F-AV-45 prior to enrollment as a screening assessment
    Other Names:
    • Florbetapir F18
    • Amyvid
Study Arms  ICMJE Experimental: FTD Subjects
Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology.
  • Drug: 18F-AV-1451
  • Drug: 18F-AV-45
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
Actual Study Completion Date  ICMJE October 24, 2018
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
  • Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
  • Can tolerate PET scan procedures

Exclusion Criteria:

  • Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
  • Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
  • Have history of drug or alcohol dependence within the last year
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
  • Have history of relevant severe drug allergy or hypersensitivity
  • Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
  • Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
  • Possess PET scan evidence of amyloid deposition
  • Determined by the investigator to be unsuitable for this type of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03040713
Other Study ID Numbers  ICMJE 18F-AV-1451-A19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
PRS Account Avid Radiopharmaceuticals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP