Tau And Connectomics In TES Study (NCT05490576) | Clinical Trial Compass
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 range40 Years – 70 Years
SexALL
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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…
What they're measuring
1
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.