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Researchers at Emory University are recruiting men for a Phase 2 trial testing whether baricitinib, an anti-inflammatory drug, affects inflammation and symptoms in former tackle-football players considered at risk for CTE. The small, open-label study will give all participants the drug for 10 weeks; it cannot establish whether they have CTE or whether the treatment works.
Emory University researchers are recruiting men for a Phase 2 clinical trial testing whether the anti-inflammatory drug baricitinib affects inflammation and symptoms in people considered at risk for chronic traumatic encephalopathy (CTE). The study targets men aged 30 to 55 who have played tackle football for at least 11 years and have depression or cognitive symptoms; it is an early test of a potential treatment, not proof that participants have CTE or that the drug can prevent it.
The researchers plan to enroll nine participants initially, with the possibility of expanding the group to 15, according to Emory associate professor Christina Gavegnano, who leads the work. The study is open label: every participant will take baricitinib for 10 weeks, and there is no placebo group for comparison. Researchers will examine whether the drug changes inflammatory markers or other measures.
The study’s main outcome measure is a brain-imaging measure related to depression. The team will also assess inflammation markers in blood, brain structure on MRI scans, and performance on cognitive and depression tests. The study is scheduled for completion in 2027, according to the report.
Baricitinib is a Janus kinase (JAK) inhibitor approved for rheumatoid arthritis and for some people hospitalized with COVID-19. The drug’s existing approvals and prior research mean the team can proceed to Phase 2 without conducting a new Phase 1 trial, Gavegnano told Being Patient. Those approvals are not evidence that it is effective against CTE.
Testing Inflammation as a Treatment Target
The trial matters because there is no established treatment for CTE, and the disease cannot currently be confirmed in a living person. Researchers instead identify people who may be at risk through their history of repeated head impacts and symptoms. Testing a drug aimed at inflammation could provide preliminary evidence about whether that process is a useful treatment target, but this small study is designed to explore the question, not settle it.
The study’s design also limits what its results can show. Because it is small and has no placebo group, any changes in participants cannot be confidently separated from expectations, extra clinical attention, or other influences. A larger controlled trial would be needed to assess whether baricitinib produces a meaningful effect and is safe and effective for this use.
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Why Emory Selected Baricitinib
Repeated head impacts have been linked to brain changes associated with CTE, including inflammation and the abnormal accumulation of tau protein. CTE itself is diagnosed through examination of brain tissue after death, and no biomarker currently confirms it in living people. That makes it difficult to know whether a person with a history of head impacts and symptoms has CTE or another condition.
Gavegnano told Being Patient that research involving thousands of athletes has produced evidence suggesting inflammation may contribute to risks of CTE and other dementias. Baricitinib blocks JAK proteins involved in inflammatory signaling, making it a way to test that hypothesis. The researcher said the team chose football players first because of the amount of prior research in that group; she said the longer-term goal is to develop treatments for everyone who may need them.
Baricitinib and other JAK inhibitors carry an FDA boxed warning about serious potential risks, including heart problems, blood clots, cancer and death. Gavegnano said the warning applies across the drug class, while some researchers believe certain risks may be tied to inhibiting JAK3. The source report does not establish that baricitinib is free of those risks; the warning remains relevant to participants and clinicians.
“You don’t have a biomarker, so you can’t know for sure that they have it [CTE].”
— Dr. Carmela Tartaglia, neurologist and researcher at the University Health Network’s Krembil Brain Institute, who is not involved in the trial
Diagnosis and Drug Effects Remain Unclear
It is not known whether participants have CTE; their football histories and symptoms identify them as potentially at risk, but do not confirm the disease. Nor is it known whether baricitinib will change the study’s measures, improve symptoms, or affect the likelihood of developing CTE. The study is too small and lacks a placebo group, so results will be preliminary.
Safety is also a continuing consideration. The FDA boxed warning for JAK inhibitors lists serious potential adverse events, and the source report does not provide trial results or establish how the risks compare for baricitinib in this population. The effects of the 10-week course and any longer-term outcomes remain unknown.
Recruitment and Results Through 2027
The immediate next step is to enroll eligible participants and complete the 10-week treatment and assessments. Researchers will evaluate imaging, blood inflammation markers, MRI findings, and cognitive and depression measures. The study is slated for completion in 2027, though the report does not give a specific date for results to be released.
If the findings support further testing, a larger, controlled trial would be needed to judge effectiveness and inform whether use should be expanded to other people at risk, including female athletes. No such expansion or later trial is confirmed yet.
Key Questions
Who can take part in the Emory trial?
The trial is recruiting men aged 30 to 55 who have played tackle football for at least 11 years and have depression or cognitive symptoms. The source report does not provide contact details or a full list of eligibility criteria.
Does the trial confirm that participants have CTE?
No. CTE cannot currently be confirmed in living people. Participants are selected based on exposure history and symptoms that may indicate risk, not a definitive diagnosis.
Will everyone receive baricitinib?
Yes. The study is open label, so all participants will receive baricitinib for 10 weeks. There is no placebo group in this trial.
Does the study show that baricitinib treats or prevents CTE?
No results are reported. The trial is testing whether the drug affects inflammation-related measures and other symptoms; it does not establish that baricitinib treats or prevents CTE.
When is the trial expected to finish?
The study is slated for completion in 2027. The report does not specify when researchers expect to publish results.
Source: rss
