UnknownPhase 1

Tau And Connectomics In TES Study

Australia12 participantsStarted 2023-02-03

Plain-language summary

This pilot study aims to assess if participants that meet the criteria for a TES diagnosis have a specific tau deposition profile on PET scanning using the PET tau binding ligand - \[18F\] PI-2620. It is hoped this study will highlight potential diagnostic tests of TES diagnosis, the in-life correlate of CTE.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

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: * The participant must have full capacity to understand the purpose and risks of the study to provide informed consent. * All participants must be between 40 to 70 years of age. * Must meet the Traumatic Encephalopathy Syndrome criteria as defined by the National Institute of Neurological Disorders and Stroke Consensus Diagnostic Criteria for Traumatic Encephalopathy Syndrome, Katz. D, et. al. Neurology, 2021. * Participants must demonstrate that they have a cognitive decline, evident by performance on neuropsychological testing. * Standard of care blood screening within 12 months of consent to the study to exclude other medical conditions which may cause cognitive decline, such as heavy metal toxicology. * A PET scan within 6 months of consent to the study that is not consistent with Alzheimer's disease. * Participants must consent to undertake Positron Emission Tomography (PET) with intravenous \[18F\] PI-2620 PET tracer ligand. * Participants must be able to lie still, on their back for up to 60 minutes for the scans. * Participants must not have any metal in their bodies e.g. pacemakers, aneurysm clips which are contraindications of MRI. * Participants must consent to the use of their medical records and medical history, including but not limited to pathology results, previous imaging results and neuropsychology results Exclusion Criteria: * Participants will be excluded if they do not meet all the inclusion criteria. * Participants must not be diag…

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.

What they're measuring

Detection of Tau protein 3R and 4R isoforms in patients who meet the Traumatic Encephalopathy Syndrome (TES) criteria, as defined by the National Institute of Neurological Disorders and Stroke.

Timeframe: 2 weeks

Trial details

NCT IDNCT05490576

SponsorMacquarie University, Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-30

View on ClinicalTrials.gov More Chronic Traumatic Encephalopathy trials