Chronic Traumatic EncephalopathyPhase 2NCT02079766

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

A Phase 2 study testing florbetapir F 18 and Flortaucipir F18 in people with Chronic Traumatic Encephalopathy, run by Avid Radiopharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Any age, men onlyHealthy volunteers can take part
Conditions the study is for: Chronic Traumatic Encephalopathy
What is being tested?: florbetapir F 18 and Flortaucipir F18
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesUnited States
Study dates: Jun 2014to Oct 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Boston University
Boston, Massachusetts, 02118
Banner Alzheimer's Institute
Phoenix, Arizona, 85006

Other trials in United States

About this study

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

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.

Conditions: Chronic Traumatic Encephalopathy
Being tested: florbetapir F 18, Flortaucipir F18
Medical subject headings: Chronic Traumatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

florbetapir F 18Drug
Also called Amyvid, 18F-AV-45
370 megabecquerel (MBq) IV single-dose
Flortaucipir F18Drug
Also called T807, 18F-AV-1451, LY3191748
370 megabecquerel (MBq) IV single-dose

Study groups in NCT02079766
Study group	Role	What they receive
High Risk of CTE	Experimental	Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players) Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18
Control	Experimental	Flortaucipir PET scans in former non-contact athletes Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18

What is being measured

The primary outcome is the main question the study is designed to answer.

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'.
Measured: 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.
Measured: baseline scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Oct 2015

First posted6 Mar 2014 (estimated)
Study startJun 2014
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Traumatic EncephalopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02079766
Sponsor's protocol ID: 18F-AV-1451-A07
Status last verified: Sep 2020
First submitted: 4 Mar 2014
Last updated: 7 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30969506

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingObservational study
A Prospective Study of Cognitive Changes in Retired and Late-Career Professional Soccer Players
Cognitive Impairment, Chronic Traumatic Encephalopathy (CTE)
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Temporal Interference Stimulation for Disorders of Consciousness
Disorder of Consciousness, Minimally Conscious State
Not yet recruitingPhase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
Traumatic Brain Injury (TBI)

All Chronic Traumatic Encephalopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
ClinicalTrials.gov ID: NCT02079766
Acronym / sponsor ID: 18F-AV-1451-A07
Conditions: Chronic Traumatic Encephalopathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 6 Mar 2014 (estimated)
Results: Posted 7 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Risk of CTE	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
Control	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18Flortaucipir PET scans in former non-contact athletes

Who may qualify

Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
florbetapir F 18Also: Amyvid, 18F-AV-45370 megabecquerel (MBq) IV single-dose	Drug	Control, High Risk of CTE
Flortaucipir F18Also: T807, 18F-AV-1451, LY3191748370 megabecquerel (MBq) IV single-dose	Drug	Control, High Risk of CTE

Primary outcome

Flortaucipir Visual Read as CTE Biomarker
Time frame: Baseline scan
Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
Time frame: baseline scan
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.

Results and safety

Results posted to the registry on 7 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Risk of CTE	30	28
Controls	11	11

Primary outcome: Flortaucipir Visual Read as CTE Biomarker

Time frame: Baseline scan. Count of participants. Unit: Participants

Measure	High Risk of CTE n = 28	Controls n = 11
No Uptake	23	11
Mild Uptake	5	0
Moderate Uptake	0	0
Intense Uptake	0	0

High Risk of CTE vs Controls: p = 0.2959, Fisher Exact

Population analysed: All subjects who received a flortaucipir scan

Primary outcome: Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)

Time frame: baseline scan. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	High Risk of CTE n = 28
No Uptake	27.348 (26.625 to 28.071)
Mild Uptake	26.800 (25.249 to 28.351)

High Risk of CTE: p = 0.5163, ANOVA

Population analysed: Only subjects at high risk for CTE were included in this analysis

Adverse events

Time frame: End of study for AE reporting was 48 hours after the last study drug administration.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Risk of CTE	0 of 29 (0%)	11 of 29 (37.9%)	0 of 29
Controls	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30969506Stern 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.

Related trials for Chronic Traumatic Encephalopathy

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingObservational study
A Prospective Study of Cognitive Changes in Retired and Late-Career Professional Soccer Players
Cognitive Impairment, Chronic Traumatic Encephalopathy (CTE)
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Temporal Interference Stimulation for Disorders of Consciousness
Disorder of Consciousness, Minimally Conscious State
Not yet recruitingPhase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
Traumatic Brain Injury (TBI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chief Medical Officer study chair

Avid Radiopharmaceuticals

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing florbetapir F 18 and Flortaucipir F18 in people with Chronic Traumatic Encephalopathy, run by Avid Radiopharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flortaucipir Visual Read as CTE Biomarker (time frame: Baseline scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02079766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.