What this study is
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.
What's being tested
- F 18 T807
Intervention · 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.
Study details
- Official title
- F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
- Sponsor
- Tammie L. S. Benzinger, MD, PhD
- Conditions
- Alzheimer Disease
- Enrolling
- 900 people
- Starts
- 2014-10-23
- Est. completion
- 2026-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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 -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington University School of Medicine
St Louis, Missouri, United States
- Kelley M Jackson · Contact314-362-1558kelleyj@wustl.edu
Recruiting
Study team
Sponsor
Tammie L. S. Benzinger, MD, PhD
Study ID IND 123119 Protocol A
Principal investigator
Tammie Benzinger, MD, PhD
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.