NCT01733355

A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807

A Phase 0, Open Label, Non-randomized, Multi-center Exploratory and Safety Study of [F-18]T807

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Avid Radiopharmaceuticals · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

\[F-18\]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.

Detailed description

Siemens Molecular Imaging (SMI) is seeking to determine if \[F-18\]T807 might be useful as a non-invasive assessment tool in the clinical evaluation of subjects with conditions associated with tau protein aggregates, such as Alzheimer's disease. The information collected under this exploratory study will not be used for diagnostic purposes, assessments of the participant's response to therapy or for clinical management of the participants. However, this exploratory study will provide baseline information on the safety, biodistribution, and dosimetry of \[F-18\]T807. These data will aid in the design of future studies of \[F-18\]T807 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of \[F-18\]T807 as the first PET imaging agent for human tau protein related pathology.

Conditions

• Alzheimers Disease
• AD

Interventions

Type	Name	Description
RADIATION	[F18] T807	Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-11-27
• Last updated: 2013-07-19

Locations

2 sites across 1 country: United States