Tau And Connectomics In TES Study

Overview

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.

Full Title of Study: “Pilot Phase 1 Clinical Trial of PET Scanning in Tau Protein Deposition and Connectome Analysis in Traumatic Encephalopathy Syndrome (TES) Cohort With a Probable Chronic Traumatic Encephalopathy (CTE) Pattern of Neurodegenerative Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 22, 2022

Interventions

  • Radiation: [18F] PI-2620 Tau Ligand
    • Tau binding ligand

Arms, Groups and Cohorts

  • Experimental: [18F] PI-2620 PET Tau Ligand Active Agent
    • Participants receive dose of active agent [18F] PI-2620 PET Tau Ligand during dynamic PET scan acquisition

Clinical Trial Outcome Measures

Primary Measures

  • To determine if participants that meet the criteria for a Traumatic Encephalopathy Syndrome (TES) diagnosis have a specific tau deposition profile on Positron Emission Tomography (PET) scanning using the PET Tau binding ligand – [18F] PI 2620
    • Time Frame: 2 weeks
    • Participants are either Tau positive or Tau negative, determined by the PET scan

Secondary Measures

  • Investigate correlations between regions of tau deposition and abnormalities observed on magnetic resonance imaging (MRI)
    • Time Frame: 2 weeks
    • Regional Tau load on PET scan compared with MRI
  • Investigate whether PET tau imaging with PI-2620 can provide a differential diagnosis between TES and other conditions associated with tauopathies e.g. Alzheimer’s disease
    • Time Frame: 2 weeks
    • By comparing PET data against reference ranges

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Macquarie University, Australia
  • Collaborator
    • Omniscient Neurotechnology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rowena Mobbs, MBBS, PhD, Principal Investigator, MQ Health
  • Overall Contact(s)
    • Eamon Brown, BMedSc, MPH, +61299005500, eamon.brown@mq.edu.au

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