F 18 T807 Tau PET Imaging of Alzheimer's Disease
Recruiting · NCT02414347 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tammie L. S. Benzinger, MD, PhD
View the official record on ClinicalTrials.gov →Interventions studied
F 18 T807
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 -
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States