Tau And Connectomics In TES Study

Last updated: February 25, 2024
Sponsor: Macquarie University, Australia
Overall Status: Active - Not Recruiting

Phase

1

Condition

Multiple Sclerosis

Memory Problems

Mild Cognitive Impairment

Treatment

[18F] PI-2620 Tau Ligand

Clinical Study ID

NCT05490576
CNTES01
  • Ages 40-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant must have full capacity to understand the purpose and risks of thestudy 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 NationalInstitute of Neurological Disorders and Stroke Consensus Diagnostic Criteria forTraumatic Encephalopathy Syndrome, Katz. D, et. al. Neurology, 2021.
  • Participants must demonstrate that they have a cognitive decline, evident byperformance on neuropsychological testing.
  • Standard of care blood screening within 12 months of consent to the study to excludeother medical conditions which may cause cognitive decline, such as heavy metaltoxicology.
  • A PET scan within 6 months of consent to the study that is not consistent withAlzheimer's disease.
  • Participants must consent to undertake Positron Emission Tomography (PET) withintravenous [18F] PI-2620 PET tracer ligand.
  • Participants must be able to lie still, on their back for up to 60 minutes for thescans.
  • Participants must not have any metal in their bodies e.g. pacemakers, aneurysm clipswhich 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 andneuropsychology results

Exclusion

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 otherneurodegenerative disease, or cerebral disease affecting cognition as identified byresults of neuropsychological evaluation or neurologist consultation.
  • Participants will be excluded if Staff at Macquarie Medical Imaging determine that theparticipant is not suitable for imaging, for any reason.
  • Participants will be excluded if they have kidney and/or liver dysfunction asdiagnosed by a doctor

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: [18F] PI-2620 Tau Ligand
Phase: 1
Study Start date:
February 03, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Macquarie Medical Imaging

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.