Chronic Traumatic EncephalopathyPhase 1TACITNCT05490576
Tau And Connectomics In TES Study
A Phase 1 study testing [18F] PI-2620 Tau Ligand in people with Chronic Traumatic Encephalopathy and Traumatic Encephalopathy, run by Macquarie University, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Head Injury Trauma
- What is being tested?
- [18F] PI-2620 Tau Ligand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Feb 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Macquarie Medical Imaging
Macquarie Park, New South Wales, 2109
About this 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
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
- Being tested
- [18F] PI-2620 Tau Ligand
- Medical subject headings
- Chronic Traumatic Encephalopathy, Brain Injuries, Traumatic, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] PI-2620 Tau LigandRadiation
Tau binding ligand
| Study group | Role | What they receive |
|---|---|---|
| [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 Receives: Radiation: [18F] PI-2620 Tau Ligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (2)
Detect disease anomalies on MRI which correlated with brain region tau deposition
Regional Tau load on PET scan compared with MRI
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start3 Feb 2023
- Primary completion30 May 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Traumatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macquarie University, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Omniscient Neurotechnology, Life Molecular Imaging GmbH
- Responsible party
- Sponsor
- Investigators
- Rowena Mobbs, MBBS, PhD, Principal investigator, MQ Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490576
- Sponsor's protocol ID
- CNTES01
- Acronym
- TACIT
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05490576
- Acronym / sponsor ID
- TACIT / CNTES01
- Conditions
- Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Head Injury Trauma, Cognitive Impairment, Neurodegenerative Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Macquarie University, AustraliaUniversity, hospital or other
- Collaborators
- Omniscient Neurotechnology, Life Molecular Imaging GmbH
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F] PI-2620 PET Tau Ligand Active Agent | Experimental | Radiation: [18F] PI-2620 Tau LigandParticipants receive dose of active agent [18F] PI-2620 PET Tau Ligand during dynamic PET scan acquisition |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F] PI-2620 Tau LigandTau binding ligand | Radiation | [18F] PI-2620 PET Tau Ligand Active Agent |
Primary outcome
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.
Time frame: 2 weeks
Participants are either Tau positive or Tau negative, determined by the PET scan
2 secondary outcomes
Detect disease anomalies on MRI which correlated with brain region tau deposition
Time frame: 2 weeks
Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Traumatic Encephalopathy
Not yet recruiting
Temporal Interference Stimulation for Disorders of Consciousness
Disorder of Consciousness, Minimally Conscious State
Not yet recruitingPhase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
Traumatic Brain Injury (TBI)
Not yet recruiting
Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
Traumatic Brain Injury
Recruiting
Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function
Traumatic Brain Injury, Stroke
Recruiting
Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rowena Mobbs, MBBS, PhD principal investigator
MQ Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] PI-2620 Tau Ligand in people with Chronic Traumatic Encephalopathy and Traumatic Encephalopathy, run by Macquarie University, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.