Phase 2
N=41
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Chronic Traumatic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT02079766 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Flortaucipir Visual Read as CTE Biomarker — 23; 11; 5; 0 Participants — p=0.2959
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- florbetapir F 18 (Drug); Flortaucipir F18 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flortaucipir Visual Read as CTE Biomarker |
23; 11; 5; 0; 0; 0 | 0.2959 |
| PRIMARY Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only) |
27.348; 26.800 | 0.5163 |
Summary
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
Eligibility Criteria
Inclusion Criteria
- Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
- Can tolerate up to two PET imaging sessions
- Have the ability to provide informed consent for study procedures
Exclusion Criteria
- Claustrophobia
- Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG
- History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results
- Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions
Data sourced from ClinicalTrials.gov (NCT02079766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.