Traumatic brain injury (TBI) results in close to 70,000 deaths in the U.S. every year, and it is the cause of long-term physical, cognitive, and mental disability in 5 million Americans. Despite decades of work, there are not any treatments specifically approved to treat TBI. In the civilian population, TBI is most often caused by motor vehicle crashes, falls, assaults, and firearm-related suicide. Older adults, as well as those facing barriers in accessing appropriate care, are the fastest-growing population with TBI and are at higher risk of disability and death. More than 300,000 service members have sustained a TBI, typically caused by blasts and explosions, vehicle crashes, and falls.

To advance the search for treatment, the TRACK-TBI NETWORK has launched an innovative phase 2 adaptive platform trial (APT) of a series of pharmaceutical agents aimed at different pathways of TBI’s injury. The trial, which is being conducted at Level 1 trauma centers across the U.S., is supported by a unique partnership with the U.S. Department of Defense, Defense Health Agency Operational Medical Systems (DHA OPMED), Warfighter Readiness, Performance, and Brain Health Project Management Office (Fort Detrick, MD). Following the conflicts in Afghanistan and Iraq, DHA OPMED has continuously supported TBI research.

The primary objective of the APT is to confirm safety and identify whether any of the active drug treatment interventions improves functional outcome in participants with TBI as compared to matching placebo, measured by the “TBI-only” score on the Glasgow Outcome Scale -Extended (GOSE 2-ways) from Week 2 to Month 3 post-injury.

Eligible participants must be confirmed to have sustained a TBI with a Glasgow Coma Scale (GCS) score between 9 and 15, a glial fibrillary acidic protein (GFAP) blood-based biomarker level between 100 – and 15,000 pg/mL, and a positive head computerized tomography (CT+) scan identifying acute TBI. As a part of this double-blind, placebo-controlled APT, participants meeting all eligibility criteria will be randomized to receive one of four possible treatment interventions: Atorvastatin calcium, Minocycline hydrochloride, Candesartan cilexetil, or matching placebo to be taken by mouth for one month. Participants must be enrolled and treated with the first dose of drug or placebo within 24 hours of injury.

Participants are currently being screened and enrolled in the trial at University of California, San Francisco and University of Pittsburgh, with additional TRACK-TBI NETWORK clinical sites activating in Spring 2025. The APT will enroll approximately 672 participants, assuming 25% attrition, to achieve 6-month follow-up for 504 participants.

More information can be found on clinicaltrials.gov.