Printed from Voxsanity (voxsanity.com.au) — NCT06860828 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Alzheimer's Disease Trial, By Invitation
NCT06860828
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- The trial is looking for former college or professional football players (around 225 people total), as well as people with no football background who will serve as a comparison group (around 75 people), and people with early-stage Alzheimer's disease (around 50 people).
- Former college football players must have played more than 6 years of football in total, including at least 3 years at the college level, and must not have played organised football or other contact sports after college.
- Former professional football players must have played 12 or more years of football in total, including at least 3 years at college and at least one professional season where they played in at least one game (verified through pro-football-reference.com).
- People joining as a comparison group (no football background) must have no symptoms at the time of screening.
- Comparison group members must never have been diagnosed with or treated for depression, bipolar disorder, anxiety, or other mental health conditions.
- Comparison group members must have no known history of traumatic brain injury or moderate-to-severe concussion.
- Comparison group members must have no history of repeated head impacts, including from contact sports (such as ice hockey, rugby, soccer, lacrosse, wrestling, boxing, gymnastics, martial arts, or kickboxing) or from active military combat or combat training involving blast exposure or combatant stick training (other sources of repeated head impacts may also apply — confirm with trial site).
- Comparison group members must have a BMI of 24 or higher, to be physically similar to the football player participants.
- Comparison group members must have completed at least 2 years of study at a 4-year accredited college or university, or hold an associate's degree if they did not attend a 4-year college.
- People joining the Alzheimer's disease group must have a Clinical Dementia Rating (CDR) score of 0.5 to 1.0, measured within 6 to 12 months of the study visit — this is a standard medical scale used to measure the severity of memory and thinking problems (confirm with trial site).
- Alzheimer's disease group members must have a positive amyloid PET scan or spinal fluid test confirming Alzheimer's-related changes in the brain, done within the past 12 months as part of their existing care or research participation.
- Alzheimer's disease group members must have no history of repeated head impacts from contact sports or military combat or combat training (as described above for the comparison group).
- Alzheimer's disease group members must have a BMI of 24 or higher.
- Alzheimer's disease group members must ideally begin the study before starting any anti-amyloid drug treatments, but those who have recently started such treatment may still be considered if the baseline study visit can be completed within 3 months of starting treatment.
- Alzheimer's disease group members must not have taken part in any previous clinical trials targeting amyloid or tau proteins before joining this study.
- A smaller sub-group of 20 professional football players from a previous related study will be invited to have two different types of brain PET scans; to be considered for this sub-group, people must be 60 years of age or older, must have played professionally, and must have had a negative amyloid PET scan at their earlier study visit.
- For the sub-group above, people must also show signs of cognitive impairment based on previous assessments, and/or show evidence of tau protein build-up on a previous brain scan (confirm with trial site for specific scoring details).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with unstable medical conditions that could make it difficult to accurately assess brain health, such as active cancer with recent chemotherapy or radiation, unstable heart disease (particularly if reliant on oxygen), or kidney disease requiring dialysis.
- People with neurological conditions that could interfere with accurately assessing brain health, such as a recent clinical stroke or a severe traumatic brain injury with ongoing symptoms (for football players, this refers to symptoms occurring after their playing career).
- People with serious mental illness that could interfere with accurately assessing brain health, such as active psychosis.
- People who are unable to complete the research activities due to physical, visual, or hearing difficulties.
- People whose primary language is not English.
- People who are unable to travel to one of the five study locations.
- People who do not have a suitable person (an "informant") who can provide information about them — this informant must be 18 or older, speak or visit with the participant at least once a week for a minimum of 6 months, be willing to fill out questionnaires, be able to travel to study visits if needed, and be knowledgeable about any changes in the participant's thinking, mood, and behaviour.
- People who are unable to give informed consent themselves and do not have a legally authorised representative or guardian who can consent on their behalf.
- People who are unwilling to attempt an MRI scan.
- People who are willing to attempt an MRI but have a medical reason they cannot safely have a 3T MRI scan, such as a pacemaker, certain types of surgical clips, an artificial heart valve, certain ear implants, certain stents, or metal fragments or foreign objects in the eyes, skin, or body.
- People who have had more than one research nuclear medicine study in the previous 12 months (a study doctor will assess this, and including such a person would require approval from the lead researchers).
- People who have taken an investigational (experimental) drug within 30 days before joining the study.
- People who have already started taking medication as part of a clinical trial targeting tau proteins before their baseline study visit.
- People with a history of a serious allergic reaction or hypersensitivity to a relevant drug.
- People who are unable to urinate.
- People with any serious illness that, in the study doctor's opinion, could interfere with completing the PET scans or could pose a safety risk.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
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Trial details
Status
By Invitation
Phase
Not Applicable
Sponsor
Boston University
Registry
ClinicalTrials.gov
Start date
9 April 2025
Est. completion
1 July 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Delayed recall memory
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.