RecruitingNCT02414347

F 18 T807 Tau PET Imaging of Alzheimer's Disease

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

Sponsor

Tammie L. S. Benzinger, MD, PhD

Enrollment

900 participants

Start Date

Oct 23, 2014

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria8

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 -

Interventions

DRUGF 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.