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This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI Subjects | Experimental | Subjects with history of recent subacute Traumatic Brain Injury (TBI) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451 2 to 6 weeks following injury. They will return for a follow-up injection approximately 6 months following injury. |
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| Control | Experimental | Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-AV-1451 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| TBI Biomarker Analysis | 18F-AV-1451 uptake will be compared in subjects with TBI and controls. | 75-105 minutes postinjection |
| Relationship Between Clinical Presentation and Tau Deposition (MMSE) | The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE). | 75-105 minutes postinjection |
| Change in tau deposition over time | Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time. | 6 months |
| Relationship Between Clinical Presentation and Tau Deposition (BIS-11) | The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11) | 75-105 minutes postinjection |
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TBI Subjects
Inclusion Criteria:
TBI Subjects
Control Subjects
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIH Clinical Center | Bethesda | Maryland | 20892 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |