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 range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 at least 1 season professionally where they played in at least 1 game (as corroborated by https://www.pro-football-reference.com)
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
Exclusion criteria
. 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 within 6-12 months of study visit
. 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.
. If possible, baseline visit should be conducted before the initiation of anti-amyloid monoclonal antibody treatments or therapeutic trials targeting amyloid; however, will allow participants that recently started treatment. Baseline must be completed within 3-months of treatment initiation.