Tau And Connectomics In TES Study (TACIT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurodegenerative Diseases; Cognitive Impairment; Head Injury Trauma; Chronic Traumatic Encephalopathy; Traumatic Encephalopathy
• Intervention / Treatment: Radiation: [18F] PI-2620 Tau Ligand

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Radiation: [18F] PI-2620 Tau Ligand; Tau binding ligand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detect disease anomalies on MRI which correlated with brain region tau deposition	Regional Tau load on PET scan compared with MRI	2 weeks
Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand	By comparing PET data against reference ranges	2 weeks

Collaborators and Investigators

• Sponsor: Macquarie University, Australia
• Collaborators: Life Molecular Imaging GmbH; Omniscient Neurotechnology
• Investigators: Principal Investigator: Rowena Mobbs, MBBS, PhD, MQ Health

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Brain Damage, Chronic; Trauma, Nervous System; Brain Injuries; Chronic Disease; Brain Injury, Chronic; Brain Injuries, Traumatic; Brain Diseases; Neurodegenerative Diseases; Craniocerebral Trauma; Chronic Traumatic Encephalopathy
• Other Study ID Numbers: CNTES01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No