Last updated: February 25, 2024
Sponsor: Macquarie University, Australia
Overall Status: Active - Not Recruiting
Phase
1
Condition
Multiple Sclerosis
Memory Problems
Mild Cognitive Impairment
Treatment
[18F] PI-2620 Tau Ligand
Clinical Study ID
NCT05490576
CNTES01
Ages 40-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The participant must have full capacity to understand the purpose and risks of thestudy 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 NationalInstitute of Neurological Disorders and Stroke Consensus Diagnostic Criteria forTraumatic Encephalopathy Syndrome, Katz. D, et. al. Neurology, 2021.
- Participants must demonstrate that they have a cognitive decline, evident byperformance on neuropsychological testing.
- Standard of care blood screening within 12 months of consent to the study to excludeother medical conditions which may cause cognitive decline, such as heavy metaltoxicology.
- A PET scan within 6 months of consent to the study that is not consistent withAlzheimer's disease.
- Participants must consent to undertake Positron Emission Tomography (PET) withintravenous [18F] PI-2620 PET tracer ligand.
- Participants must be able to lie still, on their back for up to 60 minutes for thescans.
- Participants must not have any metal in their bodies e.g. pacemakers, aneurysm clipswhich 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 andneuropsychology results
Exclusion
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 otherneurodegenerative disease, or cerebral disease affecting cognition as identified byresults of neuropsychological evaluation or neurologist consultation.
- Participants will be excluded if Staff at Macquarie Medical Imaging determine that theparticipant is not suitable for imaging, for any reason.
- Participants will be excluded if they have kidney and/or liver dysfunction asdiagnosed by a doctor
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: [18F] PI-2620 Tau Ligand
Phase: 1
Study Start date:
February 03, 2023
Estimated Completion Date:
December 31, 2024
Connect with a study center
Macquarie Medical Imaging
Macquarie Park, New South Wales 2109
AustraliaSite Not Available

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