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NCT Number: NCT02414347

F 18 T807 Tau PET Imaging of Alzheimer's Disease

A single-center, open-label baseline controlled imaging study designed to assess whether brain tau fibril uptake of flortaucipir as measured by PET correlates with cognitive status of individuals with and without brain tau fibrils.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Kelley M Jackson

CONTACT

[email protected]

314-362-1558

About this study

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 and without brain tau fibrils. 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.

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 18 years of age.
  • Cognitively normal, or with mild dementia, as assessed clinically
  • 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 undergo a urine pregnancy test within 24 hours of 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: currently on anticoagulant of any form -

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

    Employing statistical parametric mapping (SPM), a voxel-based analytic measure in order to quantify and co-localize the imaging patterns from the multiple imaging datasets in this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelley M Jackson, BA

CONTACT

[email protected]

314 362-1558

Sponsors and collaborators

Lead sponsor

Tammie L. S. Benzinger, MD, PhD

Other

Registry information

Official study title

F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A

Acronym: T807IND

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2015
Registry last updated
Jun 8, 2026

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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