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OpenTrials
Completed

NCT Number: NCT02278367

Clinical Evaluation of Flortaucipir F 18

This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner Alzheimer's Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.

Inclusion criteria

  • Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study

Exclusion criteria

  • Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
  • Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
  • Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have a history of relevant severe drug allergy or hypersensitivity
  • Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
  • Are patients with current clinically significant unstable medical comorbidities
  • Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study

Treatment and study plan

Flortaucipir F18

Drug

IV injection, 370 MBq (10 mCi), up to two doses

Other names: [F-18]T807, 18F-AV-1451, LY3191748, Tauvid

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain

Primary outcomes

  1. Number of Participants With Adverse Events Related to Flortaucipir Administration

    Time frame: within 48 hours of drug administration

    Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.

    (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).

  2. Flortaucipir PET Scan SUVr

    Time frame: baseline and follow-up scans

    Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

Clinical Evaluation of 18F-AV-1451

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2014
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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