NCT02079766

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

March 4, 2014

Results QC Date

June 27, 2020

Last Update Submit

September 3, 2020

Conditions

Chronic Traumatic Encephalopathy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

High Risk of CTE

EXPERIMENTAL

Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)

Drug: florbetapir F 18Drug: Flortaucipir F18

Control

EXPERIMENTAL

Flortaucipir PET scans in former non-contact athletes

Drug: florbetapir F 18Drug: Flortaucipir F18

Interventions

florbetapir F 18DRUG

370 megabecquerel (MBq) IV single-dose

Also known as: Amyvid, 18F-AV-45
ControlHigh Risk of CTE
Flortaucipir F18DRUG

370 megabecquerel (MBq) IV single-dose

Also known as: T807, 18F-AV-1451, LY3191748
ControlHigh Risk of CTE

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Related 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 Football League Players. N Engl J Med. 2019 May 2;380(18):1716-1725. doi: 10.1056/NEJMoa1900757. Epub 2019 Apr 10.

    PMID: 30969506RESULT

MeSH Terms

Conditions

Chronic Traumatic Encephalopathy

Interventions

florbetapir7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Injury, ChronicNeurodegenerative DiseasesCraniocerebral TraumaTrauma, Nervous SystemBrain Damage, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Results Point of Contact

Title
Medical Director
Organization
Avid Radiopharmaceuticals, Inc.
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 7, 2020

Results First Posted

September 7, 2020

Record last verified: 2020-09

Locations

US(2)