Alzheimer's DiseasePhase 1NCT02278354

Tau Imaging in Professional Fighters

A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in United States.

Completed

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

Official record

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Trial summary

Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Alzheimer's Disease
What is being tested?: Flortaucipir F18 and Brain PET scan
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 18 Feb 2015to 3 Feb 2017
Phase: Phase 1
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

All Subjects
Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
Can tolerate Positron Emission Tomography (PET) scan procedures
Have the ability to provide informed consent
Subjects with cognitive impairment
Have subjective cognitive complaints or objective decline or impairment as determined by the investigator

Who cannot join

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 electrocardiogram
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
Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
Have current drug or alcohol dependence or alcohol dependence within the past 2 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106

Other trials in United States

About this study

Official title: 18F-AV-1451 PET Imaging in Professional Fighters

Conditions: Alzheimer's Disease
Being tested: Flortaucipir F18, Brain PET scan
Medical subject headings: Alzheimer Disease

What participants receive

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

Flortaucipir F18Drug
Also called [F-18]T807, 18F-AV-1451, LY3191748, Tauvid
IV injection, 370 megabecquerel (MBq) (10 mCi)
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain 75-105 minutes post injection

Study groups in NCT02278354
Study group	Role	What they receive
Active Professional Fighters	Experimental	Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan
Retired Professional Fighters	Experimental	Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan

What is being measured

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

Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline scan
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline scan
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Measured: baseline scan
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
Measured: baseline scan

Timeline

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

18 Feb 20153 Feb 2017

First posted30 Oct 2014 (estimated)
Study start18 Feb 2015
Primary completion3 Feb 2017
Study completion3 Feb 2017

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.
Other trials for Alzheimer's DiseaseStudies 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 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02278354
Sponsor's protocol ID: 18F-AV-1451-A11
Status last verified: Aug 2020
First submitted: 28 Oct 2014
Last updated: 10 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 18F-AV-1451 PET Imaging in Professional Fighters
ClinicalTrials.gov ID: NCT02278354
Acronym / sponsor ID: 18F-AV-1451-A11
Conditions: Alzheimer's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The Cleveland Clinic
Study start: 18 Feb 2015 (actual)
Primary completion: 3 Feb 2017 (actual)
Study completion: 3 Feb 2017 (actual)
First posted: 30 Oct 2014 (estimated)
Results: Posted 10 Sep 2020

Clinical summary

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

Study design

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

Arm	Type	Receives
Active Professional Fighters	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanActive professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Retired Professional Fighters	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanRetired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

All Subjects
Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
Can tolerate Positron Emission Tomography (PET) scan procedures
Have the ability to provide informed consent
Subjects with cognitive impairment

Key exclusion criteria (7 listed)

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 electrocardiogram
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

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
Flortaucipir F18Also: [F-18]T807, 18F-AV-1451, LY3191748, TauvidIV injection, 370 megabecquerel (MBq) (10 mCi)	Drug	Active Professional Fighters, Retired Professional Fighters
Brain PET scanpositron emission tomography (PET) scan of the brain 75-105 minutes post injection	Procedure or surgery	Active Professional Fighters, Retired Professional Fighters

Primary outcome

Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Time frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Time frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Time frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Time frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups

Results and safety

Results posted to the registry on 10 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
Active Professional Fighters	12	8
Retired Professional Fighters	23	20

Primary outcome: Flortaucipir Imaging (Quantitative) Between Cognitive Groups

Time frame: baseline scan. Least squares mean (95% Confidence Interval). Unit: standardized uptake value ratio (SUVr)

Measure	Cognitively Impaired Fighters n = 18	Cognitively Normal Fighters n = 12
Weighted cortical average	1.0048 (0.977 to 1.0327)	0.971 (0.9401 to 1.002)
Frontal	0.9731 (0.9394 to 1.0068)	0.9357 (0.8983 to 0.9732)
Temporal	0.9867 (0.9425 to 1.0309)	0.9305 (0.8812 to 0.9797)
Parietal	0.9472 (0.9097 to 0.9847)	0.9288 (0.8871 to 0.9705)
Occipital	0.9513 (0.912 to 0.9906)	0.9247 (0.8809 to 0.9684)

Population analysed: Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.

Primary outcome: Flortaucipir Imaging (Quantitative) Between Fighter Groups

Time frame: baseline scan. Least squares mean (95% Confidence Interval). Unit: standardized uptake value ratio (SUVr)

Measure	Active Professional Fighters n = 10	Retired Professional Fighters n = 20
Weighted cortical average	0.9965 (0.963 to 1.0299)	0.9794 (0.9546 to 1.0042)
Frontal	0.9816 (0.9411 to 1.022)	0.9273 (0.8973 to 0.9572)
Temporal	0.9838 (0.9306 to 1.0369)	0.9334 (0.894 to 0.9728)
Parietal	0.9623 (0.9172 to 1.0073)	0.9137 (0.8803 to 0.9471)
Occipital	0.9632 (0.916 to 1.0105)	0.9127 (0.8777 to 0.9478)

Primary outcome: Flortaucipir Imaging (Qualitative) Between Cognitive Groups

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

Measure	Cognitively Impaired Fighters n = 18	Cognitively Normal Fighters n = 12
No Uptake	16	12
Mild Uptake	2	0
Moderate Uptake	0	0
Intense Uptake	0	0

Population analysed: Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.

Primary outcome: Flortaucipir Imaging (Qualitative) Between Fighter Groups

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

Measure	Active Professional Fighters n = 10	Retired Professional Fighters n = 20
No Uptake	10	18
Mild Uptake	0	2
Moderate Uptake	0	0
Intense Uptake	0	0

Adverse events

Time frame: End of study for AE reporting was 48 hours after the last study drug administration.. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Professional Fighters	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Retired Professional Fighters	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site 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 6 inclusion and 7 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 10 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 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 Imaging (Quantitative) Between Cognitive Groups (time frame: baseline scan). The study lists 4 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 NCT02278354.

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 10 Sep 2020.