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Completed

NCT Number: NCT03040713

Flortaucipir PET Imaging in Subjects With FTD

This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Movement Disorder Center, UCSD, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
  • 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

Treatment and study plan

Flortaucipir F18

Drug

370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose

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

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain

Primary outcomes

  1. Qualitative Evaluation of Flortaucipir PET Scans

    Time frame: baseline scan

    Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.

  2. Quantitative Evaluation of Flortaucipir PET Scans

    Time frame: baseline scan

    Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. 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

18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2017
Registry last updated
Sep 25, 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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