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Flortaucipir PET Imaging in Subjects With FTD

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ClinicalTrials.gov Identifier: NCT03040713
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Drug: 18F-AV-1451 Drug: 18F-AV-45 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03040713


Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, California
Movement Disorder Center, UCSD Recruiting
La Jolla, California, United States, 92037
Contact    858-822-5786      
Principal Investigator: Irene Litvan         
Memory and Aging Center, UCSF Recruiting
San Francisco, California, United States, 94158
Contact    415-353-3266      
Principal Investigator: Gil Rabinovici         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact    214-648-6091      
Principal Investigator: Diana Kerwin         
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT03040713     History of Changes
Other Study ID Numbers: 18F-AV-1451-A19
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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