Recruiting

Flortaucipir

Sponsor:

Tammie L. S. Benzinger, MD, PhD

Code:

NCT02414347

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

F 18 T807

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Study ID

NCT02414347

Start date

Oct 23, 2014

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female participants, at least 18 years of age.
2. Cognitively normal, or with mild dementia, as assessed clinically
3. 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).
4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion Criteria:

1. 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).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. 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.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
8. For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Experimental F 18 T807

Participants will undergo a PET scan using the flortaucipir imaging tracer

Interventions

F 18 T807

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kelley M Jackson, BA

314 362-1558kelleyj@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Tammie L. S. Benzinger, MD, PhD

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Dementia
  • Tauopathies
  • Brain Diseases
  • Central Nervous System Diseases
  • Mild Cognitive Impairment
  • Nervous System Diseases
  • Neurodegenerative Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tammie L. S. Benzinger, MD, PhD on 2026-06-08.