Tau And Connectomics In TES Study (TACIT)

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    12
  • sponsor
    Macquarie University, Australia
Updated on 4 October 2022
stroke
neuropsychological assessment

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.

Details
Condition Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Head Injury Trauma, Cognitive Impairment, Neurodegenerative Diseases
Treatment [18F] PI-2620 Tau Ligand
Clinical Study IdentifierNCT05490576
SponsorMacquarie University, Australia
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 diagnosed with or suspected to be suffering from any other neurodegenerative disease, or cerebral disease affecting cognition as identified by results of neuropsychological evaluation or neurologist consultation
Participants will be excluded if Staff at Macquarie Medical Imaging determine that the participant is not suitable for imaging, for any reason
Participants will be excluded if they have kidney and/or liver dysfunction as diagnosed by a doctor
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