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Study was terminated in anticipation of transfer of ownership to Avid Radiopharmaceuticals.
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[F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tau diagnostic | Experimental | Experimental: Tau diagnostic [F18] T808 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [F18] T808 | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To monitor and assess the safety of IV administration of [F-18]T808 | 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 | up to15 days per patient. |
| Measure | Description | Time Frame |
|---|---|---|
| To begin collection of baseline [F-18]T808 PET/CT imaging data | 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 | up to14 days per patient |
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Low Probability for AD Participants (Group 1)
High Probability for AD Participants (Group 2)
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Irvine | California | 92697 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016875 | tau Proteins |
| ID | Term |
|---|---|
| D008869 | Microtubule-Associated Proteins |
| D008868 | Microtubule Proteins |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
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|
| Los Angeles |
| California |
| 90033 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |