A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807
- Conditions
- Alzheimers DiseaseAD
- Interventions
- Radiation: [F18] T807
- Registration Number
- NCT01733355
- Lead Sponsor
- Avid Radiopharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tau diagnostic [F18] T807 \[F18\] T807
- Primary Outcome Measures
Name Time Method To evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging up to 15 days per patient To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration up to 15 days per patient To evaluate [F-18]T807 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 upto 15 days per patient To assess the safety of IV administration of [F-18]T807 up to 24 hours post [F18]T807 administration Safety will be monitored for all subjects by the:
* Number of subjects experiencing adverse events from baseline to 24 hours post-administration.
* Number and type of adverse events.
* Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration.
* Changes in physical examination from baseline to 24 hours post administration.
* Changes in vital sign measurements (systolic blood pressure \[mmHg\]; diastolic blood pressure \[mmHg\], pulse rate \[bpm\] and body temperature) from baseline prior to \[F-18\]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration.
* Changes in ECG measurements, from baseline prior to \[F-18\]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.
- Secondary Outcome Measures
Name Time Method To begin collection of baseline [F-18]T807 PET/CT imaging data up to 15 days per patient The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of \[F-18\]T807
To gain information to improve the study design for the conduct of future trials up to 15 days per patient The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of \[F-18\]T807
Trial Locations
- Locations (1)
Research Site
🇺🇸Los Angeles, California, United States