Tau And Connectomics In TES Study

NCT ID: NCT05490576

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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

Group Type: EXPERIMENTAL

[18F] PI-2620 Tau Ligand

Intervention Type: RADIATION

Tau binding ligand

Interventions

[18F] PI-2620 Tau Ligand

Tau binding ligand

Intervention Type: RADIATION

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omniscient Neurotechnology

INDUSTRY

Sponsor Role: collaborator

Life Molecular Imaging GmbH

INDUSTRY

Sponsor Role: collaborator

Macquarie University, Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rowena Mobbs, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

MQ Health

Locations

Macquarie Medical Imaging

Macquarie Park, New South Wales, Australia

Countries

Australia

Other Identifiers

CNTES01

Identifier Type: -

Identifier Source: org_study_id