The DIAGNOSE CTE Research Project-II (NCT06860828) | Clinical Trial Compass
By InvitationNot Applicable
The DIAGNOSE CTE Research Project-II
United States350 participantsStarted 2025-04-09
Plain-language summary
Each year, millions of people are exposed to repetitive head impacts (RHI) through contact sports. RHI can result in concussions and asymptomatic non-concussions to confer risk for Alzheimer's disease (AD) and related dementias (ADRD) including chronic traumatic encephalopathy (CTE). Presently, a diagnosis of CTE can only be rendered at autopsy and it has been neuropathological diagnosed in several hundreds of American football players particularly those who played at elite levels (college and professional). The ability to make an accurate diagnosis of CTE is needed to facilitate research on risk factors, mechanisms, prevention, and treatment.
In 2015, the investigators were awarded a NINDS funded 7-year U01 known as the DIAGNOSE CTE Research Project (NCT02798185) designed to develop biomarkers, characterize the clinical presentation, and examine genetic and RHI risk factors for CTE. This current 5-year NIH funded multicenter study DIAGNOSE CTE Research Project-II will build on and extend those findings.
Who can participate
Age range50 Years
SexMALE
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Inclusion criteria
✓. Former college or professional football players (n=225) will include those retained from DIAGNOSE-I (n=150) and newly recruited (n=75). Criteria will include
✓. Former college football players must have played more than 6 years of football including 3 or more years at the college level. They must not have played organized football or other contact sports following college.
✓. Former professional football players must have played 12 or more years of total football including 3 or more years in college and 4 or more seasons professionally.
✓. Control (n=75) will include those retained from DIAGNOSE-I (n=50) and newly recruited (n=25). Inclusion criteria for control include:
✓. Asymptomatic at screening
✓. Never been diagnosed with, or treated for, any of the following: depression, manic-depressive or bipolar disorder, anxiety, or other psychiatric or mental health problems
✓. No known traumatic brain injury (TBI) and/or moderate/severe concussion (severity determined on phone screening).
. BMI of 24 or higher to be similar in body habitus to former professional and college football players.
✕. Must have at least 2 years of post-secondary education at a 4-year accredited college or university or have an associate's degree if they did not attend a 4-year accredited college or university.
✕. AD-CI (n=50) will come from the local ADRCs where Clinical Dementia Rating (CDR) and amyloid biomarker status are known for most participants being followed annually. Inclusion criteria include:
✕. CDR of 0.5-1.0
✕. Positive amyloid PET or CSF AD biomarker within 12 months of study visit (done as part of their participation in the local ADRCs and/or clinical care).
✕. No history of RHI including participation in contact and collision sports (i.e., football, ice hockey, rugby, soccer, lacrosse, wrestling, boxing gymnastics, martial arts, kickboxing), or military service (refers to active combat experience or combat training involving exposure to IED blasts or combatant stick training). These are examples and there might be instances of other RHI sources that could be exclusionary as determined by investigators.
✕. BMI of 24 or higher to be similar in body habitus to former professional and college football players.
✕. No prior anti-amyloid monoclonal antibody treatments or therapeutic trials targeting amyloid or tau prior to initiating study