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Tau And Connectomics In TES Study (TACIT)

Primary Purpose

Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Head Injury Trauma

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
[18F] PI-2620 Tau Ligand
Sponsored by
Macquarie University, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Traumatic Encephalopathy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Macquarie Medical ImagingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Detect disease anomalies on MRI which correlated with brain region tau deposition
Regional Tau load on PET scan compared with MRI
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

Full Information

First Posted
August 4, 2022
Last Updated
August 21, 2022
Sponsor
Macquarie University, Australia
Collaborators
Omniscient Neurotechnology, Life Molecular Imaging GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05490576
Brief Title
Tau And Connectomics In TES Study
Acronym
TACIT
Official Title
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
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Anticipated)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
December 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macquarie University, Australia
Collaborators
Omniscient Neurotechnology, Life Molecular Imaging GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Head Injury Trauma, Cognitive Impairment, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F] PI-2620 PET Tau Ligand Active Agent
Arm Type
Experimental
Arm Description
Participants receive dose of active agent [18F] PI-2620 PET Tau Ligand during dynamic PET scan acquisition
Intervention Type
Radiation
Intervention Name(s)
[18F] PI-2620 Tau Ligand
Intervention Description
Tau binding ligand
Primary Outcome Measure Information:
Title
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.
Description
Participants are either Tau positive or Tau negative, determined by the PET scan
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Detect disease anomalies on MRI which correlated with brain region tau deposition
Description
Regional Tau load on PET scan compared with MRI
Time Frame
2 weeks
Title
Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand
Description
By comparing PET data against reference ranges
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eamon Brown, BMedSc, MPH
Phone
+61299005500
Email
eamon.brown@mq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rowena Mobbs, MBBS, PhD
Organizational Affiliation
MQ Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macquarie Medical Imaging
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margery Pardey, PhD
Phone
+6129430 1100
Email
margery.pardey@mq.edu.au
First Name & Middle Initial & Last Name & Degree
John Magnussen, MBBS, PhD
First Name & Middle Initial & Last Name & Degree
Rowena Mobbs, MBBS, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tau And Connectomics In TES Study

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