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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05490576




Registration number
NCT05490576
Ethics application status
Date submitted
4/08/2022
Date registered
5/08/2022

Titles & IDs
Public title
Tau And Connectomics In TES Study
Scientific 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
Secondary ID [1] 0 0
CNTES01
Universal Trial Number (UTN)
Trial acronym
TACIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Traumatic Encephalopathy 0 0
Traumatic Encephalopathy 0 0
Head Injury Trauma 0 0
Cognitive Impairment 0 0
Neurodegenerative Diseases 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - [18F] PI-2620 Tau Ligand

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


Treatment: Other: [18F] PI-2620 Tau Ligand
Tau binding ligand
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Detect disease anomalies on MRI which correlated with brain region tau deposition
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand
Timepoint [2] 0 0
2 weeks

Eligibility
Key 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
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie Medical Imaging - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Omniscient Neurotechnology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Life Molecular Imaging GmbH
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rowena Mobbs, MBBS, PhD
Address 0 0
MQ Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05490576