18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

Chronic Traumatic Encephalopathy Clinical Trial

Official title:

18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079766
• Other study ID #: 18F-AV-1451-A07
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy

Intervention

Drug:
• florbetapir F 18
370 megabecquerel (MBq) IV single-dose
• Flortaucipir F18
370 megabecquerel (MBq) IV single-dose

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	Banner Alzheimer's Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stern RA, Adler CH, Chen K, Navitsky M, Luo J, Dodick DW, Alosco ML, Tripodis Y, Goradia DD, Martin B, Mastroeni D, Fritts NG, Jarnagin J, Devous MD Sr, Mintun MA, Pontecorvo MJ, Shenton ME, Reiman EM. Tau Positron-Emission Tomography in Former National F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flortaucipir Visual Read as CTE Biomarker	Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.	Baseline scan
Primary	Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)	The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group.	baseline scan