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Emory University is recruiting men aged 30 to 55 for a small, open-label Phase 2 trial of baricitinib, an anti-inflammatory drug, in former tackle football players with depression or cognitive symptoms. The study will test changes in symptoms and inflammation-related measures, but participants cannot be confirmed to have CTE during life, and the trial will not establish whether the drug prevents or treats the disease.
Emory University researchers are recruiting men aged 30 to 55 for a Phase 2 trial testing whether the anti-inflammatory drug baricitinib affects symptoms or biological measures in former tackle football players considered at risk for chronic traumatic encephalopathy (CTE). The small, open-label study is an early test of a possible treatment approach, not a way to confirm CTE or establish that the drug prevents it.
The trial is seeking men who have played tackle football for at least 11 years and have depression or cognitive symptoms. According to the report by Being Patient, researchers plan to enroll nine participants initially, with the possibility of increasing enrollment to 15. All participants will receive baricitinib for 10 weeks; there is no placebo group.
Researchers will examine a brain-imaging measure related to depression, blood markers of inflammation, MRI measures of brain structure, and results from cognitive and depression tests. The study is designed to assess whether the drug has effects on these measures over the treatment period. It is not a definitive test of clinical benefit, and the open-label design means participants and researchers know that the drug is being given.
Baricitinib is a Janus kinase, or JAK, inhibitor. It is approved for rheumatoid arthritis and for certain people hospitalized with COVID-19, according to the source report. Trial lead Christina Gavegnano, an associate professor at Emory University School of Medicine and the Center for the Study of Human Health, told Being Patient that existing research on the drug allows the team to move directly to Phase 2 rather than conduct a Phase 1 trial for this study. FDA approval for other conditions does not establish that it is safe or effective for CTE.
A Small Test of Inflammation
The study tests a proposed biological pathway: that inflammation may contribute to brain changes associated with repeated head impacts. If the researchers observe changes in inflammatory markers or symptoms, that could help guide further research. But a nine-to-15-person study lasting 10 weeks cannot establish that baricitinib changes the long-term risk of CTE or works as a treatment for the disease.
The work also addresses a major obstacle in CTE research. CTE is currently diagnosed through examination of brain tissue after death, and there is no established biomarker that can confirm the disease in a living person. Participants are selected based on football history and symptoms that may signal risk; those criteria do not prove that an individual has CTE. The distinction matters for interpreting any trial result and for deciding who might benefit from a future treatment.
The reported FDA black-box warning for JAK inhibitors is another reason the trial’s safety monitoring and later research matter. The source report says the warning followed concerns about serious outcomes associated with another JAK inhibitor. Gavegnano told Being Patient that baricitinib mainly targets JAK1 and JAK2 and that she views some risks as linked to JAK3 inhibition; that is her explanation, not evidence that baricitinib is free of serious risks.
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Why Football Players Were Selected
CTE is associated with repeated head impacts and has been identified after death in people with histories that include contact sports. The source report describes changes involving inflammation and the abnormal folding and tangling of proteins such as tau. However, researchers cannot use those postmortem findings to confirm CTE in a living trial participant.
Emory’s team is starting with men who played tackle football because, Gavegnano told Being Patient, extensive research has already been conducted in thousands of football players. She said the broader goal is to develop treatments that could reach everyone in need. The report says a promising early result could support planning a larger, more definitive trial and research involving other groups at risk, including female athletes. That future work has not yet been established by this small study.
“You don’t have a biomarker, so you can’t know for sure that they have it [CTE].”
— Carmela Tartaglia, neurologist and researcher at the University Health Network’s Krembil Brain Institute, speaking to Being Patient
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Limits of Diagnosis and Trial Design
It is not yet clear whether baricitinib will change the study’s imaging, blood, MRI, or cognitive measures. The report does not provide trial results, and the study is still recruiting. Because every participant will receive the drug and there is no placebo group, any changes cannot be cleanly separated from placebo effects, clinical attention, or other influences.
Researchers also cannot know from symptoms and football history alone whether a participant has CTE. Depression and cognitive problems can have multiple causes. The small sample and short treatment period mean the trial is not designed to show whether the drug prevents CTE, slows its development, or improves long-term outcomes. Safety and tolerability in this particular group are also questions the study must assess.
The source report notes that baricitinib carries a boxed warning shared by JAK inhibitors, concerning serious risks including heart disease, blood clots, cancer, and death. Gavegnano said the team considers baricitinib’s JAK targets and the evidence behind the class-wide warning when assessing the drug. The trial’s findings will be needed to clarify what can be said about its use in this population; the report does not establish that the medication is safe for athletes at risk of CTE.
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Recruitment and 2027 Results
Emory is recruiting eligible participants for the 10-week study, which the report says is slated for completion in 2027. The next key information will be whether enrollment reaches the initial target of nine or expands to as many as 15, and what the trial reports about its measured outcomes and safety.
If results support further investigation, researchers could use them to plan a larger controlled study. Such a trial would need to address the limitations of the open-label design and would still face the challenge of identifying participants with CTE while they are alive. The current study’s completion does not itself mean baricitinib will be approved for CTE or that its use will extend to women or other groups.
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Key Questions
What is the Emory trial testing?
It is testing whether 10 weeks of baricitinib affects selected depression-related imaging measures, inflammation markers in blood, MRI measures, or cognitive and depression test results in former tackle football players with symptoms.
Who can take part?
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, according to the source report.
Can participants be confirmed to have CTE?
No. CTE is currently confirmed through examination of brain tissue after death. There is no established biomarker that confirms CTE in living people, so the trial uses football history and symptoms to identify people considered at risk.
Does the trial show that baricitinib prevents CTE?
No. The study is small, open-label, and has no placebo group. Its measures may inform future research, but it cannot establish that the drug prevents CTE, treats it, or changes long-term disease risk.
When is the study expected to finish?
The source report says the study is slated for completion in 2027. It does not provide a results date or confirm how many participants have enrolled so far.
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