Tau And Connectomics In TES Study

NCT05490576 | Active Not Recruiting Phase 1

• 1 other identifier: CNTES01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Traumatic Encephalopathy; Traumatic Encephalopathy; Head Injury Trauma; Cognitive Impairment; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (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.

  Participants are either Tau positive or Tau negative, determined by the PET scan

  2 weeks

Secondary Outcomes (2)

• Detect disease anomalies on MRI which correlated with brain region tau deposition

  2 weeks

• Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand

  2 weeks

Study Arms (1)

[18F] PI-2620 PET Tau Ligand Active Agent

EXPERIMENTAL

Participants receive dose of active agent \[18F\] PI-2620 PET Tau Ligand during dynamic PET scan acquisition

Radiation: [18F] PI-2620 Tau Ligand

Interventions

[18F] PI-2620 Tau Ligand RADIATION

Tau binding ligand

[18F] PI-2620 PET Tau Ligand Active Agent

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Macquarie University, Australia: lead
• Omniscient Neurotechnology: collaborator
• Life Molecular Imaging GmbH: collaborator

Study Sites (1)

Macquarie Medical Imaging

Macquarie Park, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Chronic Traumatic Encephalopathy; Brain Injuries, Traumatic; Cognitive Dysfunction; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injury, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rowena Mobbs, MBBS, PhD

  MQ Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: February 3, 2023
• Primary Completion: May 30, 2023
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

AU (1)