A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808

Early Phase 1

Terminated

• Conditions: Alzheimers Disease
• Interventions: Radiation: [F18] T808

• Registration Number: NCT01723488
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

\[F-18\]T808 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 \[F-18\]T808 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 \[F-18\]T808. These data will aid in the design of future studies of \[F-18\]T808 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of \[F-18\]T808 as the first PET imaging agent for human tau protein related pathology.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tau diagnostic	[F18] T808	Experimental: Tau diagnostic \[F18\] T808

Primary Outcome Measures

Name	Time	Method
To monitor and assess the safety of IV administration of [F-18]T808	up to15 days per patient.	To monitor and assess the safety of IV administration of \[F-18\]T808 To evaluate the bio-distribution and radiation dosimetry of \[F-18\]T808 in participants with low probability of Alzheimer"s disease (AD) using PET/CT whole body imaging To evaluate the metabolism of \[F-18\]T808 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration To evaluate \[F-18\]T808 uptake and signal/background information in brain PET/CT imaging of participants with a high probability of currently being positive for AD and age-matched participants with a low probability of currently being positive for AD

Secondary Outcome Measures

Name	Time	Method
To begin collection of baseline [F-18]T808 PET/CT imaging data	up to14 days per patient	To begin collection of baseline \[F-18\]T808 PET/CT imaging data To gain information to improve the study design for the conduct of future trials

Trial Locations

Locations (1)

Research Site; 🇺🇸 Los Angeles, California, United States