Traumatic Brain Injury
Conditions
Brief summary
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.
Interventions
DRUG18F-AV-1451
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TBI Biomarker Analysis | 75-105 minutes postinjection | 18F-AV-1451 uptake will be compared in subjects with TBI and controls. |
| Relationship Between Clinical Presentation and Tau Deposition (MMSE) | 75-105 minutes postinjection | The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE). |
| Change in tau deposition over time | 6 months | Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time. |
| Relationship Between Clinical Presentation and Tau Deposition (BIS-11) | 75-105 minutes postinjection | The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11) |
Countries
United States
Outcome results
None listed