18F-AV-1451 PET Imaging in TBI

Study Overview
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Brief Summary
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This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.

Official Title
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18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: 18F-AV-1451


Participation Criteria
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Eligibility Criteria
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TBI Subjects Inclusion Criteria: TBI Subjects Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084 History of having sustained a TBI < 6 weeks prior to enrollment Can tolerate PET and MRI scan procedures Control Subjects MMSE ≥ 28 No significant history of cognitive impairment No prior history of TBI Can tolerate PET and MRI scan procedures Exclusion Criteria: Have behavior dysfunction that is likely to interfere with imaging Are claustrophobic or otherwise unable to tolerate the imaging procedure Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18F-AV-1451 imaging session Have current alcohol dependence or alcohol dependence within the past 1 year Are currently participating in another interventional clinical trial Have evidence of a penetrating brain injury Have participated in contact sports in college or after high school age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBI Subjects<br>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. | Drug: 18F-AV-1451<br> <br> * Other names: [F-18]T807;|
| Experimental: Control<br>Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451. | Drug: 18F-AV-1451<br> <br> * Other names: [F-18]T807;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |