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Completed

NCT Number: NCT02414282

F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction (IND 123119, Protocol E)

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with Progressive Posterior Cortical Dysfunction (PPCD) and logopenic variant primary progressive aphasia (lvPPA). The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female participants, at least 45 years of age.
  • Clinical diagnosis of PPCD.
  • Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
  • Pre-menopausal women will have a negative urine pregnancy test within 24 hours of T807 drug administration.

Exclusion criteria

  • Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
  • Is deemed likely unable to perform the imaging procedures for any reason.
  • Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
  • Has hypersensitivity to F 18 T807 or any of its excipients.
  • Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
  • Severe claustrophobia.
  • Currently pregnant or breast-feeding.
  • For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.

Treatment and study plan

F 18 T807

Drug

Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.

Other names: 18F-AV-1451

Primary outcomes

  1. F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Tammie L. S. Benzinger, MD, PhD

Other

Registry information

Official study title

F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction Due to Alzheimer Disease

Acronym: Protocol E

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2015
Registry last updated
Jan 19, 2021

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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