Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Traumatic Encephalopathy Cognitive Impairment Head Injury Trauma Neurodegenerative Diseases Traumatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

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
2 weeks

Secondary Outcomes (2)

Detect disease anomalies on MRI which correlated with brain region tau deposition
2 weeks
Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand
2 weeks

Study Arms (1)

[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

Radiation: [18F] PI-2620 Tau Ligand

Interventions

[18F] PI-2620 Tau LigandRadiation

Tau binding ligand

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Life Molecular Imaging GmbH
Industrycollaborator
Macquarie University, Australia
Otherlead
Omniscient Neurotechnology

Study Sites (1)

Macquarie Medical Imaging

Macquarie Park, New South Wales, 2109, Australia

MeSH Terms

Conditions

Chronic Traumatic EncephalopathyBrain Injuries, TraumaticCognitive DysfunctionNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Injury, ChronicCraniocerebral TraumaTrauma, Nervous SystemBrain Damage, ChronicChronic DiseaseDisease AttributesPathologic Processes

Study Officials

Rowena Mobbs, MBBS, PhD
MQ Health
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 5, 2022

Study Start

February 3, 2023

Actual (reported)

Primary Completion

Tau And Connectomics In TES Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations