Clinical trial NCT05490576: Tau And Connectomics In TES Study
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Chronic Traumatic Encephalopathy
Traumatic Encephalopathy
Head Injury Trauma
Cognitive Impairment
Neurodegenerative Diseases
Lead sponsor: Macquarie University, Australia
Sponsor class: OTHER
Collaborators: name: Omniscient Neurotechnology
name: Life Molecular Imaging GmbH
First posted: 2022-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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.
timeFrame: 2 weeks
Secondary outcomes:
measure: Detect disease anomalies on MRI which correlated with brain region tau deposition
timeFrame: 2 weeks
measure: Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Macquarie Medical Imaging
state: New South Wales
Study officials:
affiliation: MQ Health
name: Rowena Mobbs, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: