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Clinical Trials/NCT04926259
NCT04926259
Recruiting
Early Phase 1

Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders

First Affiliated Hospital of Fujian Medical University1 site in 1 country50 target enrollmentNovember 1, 2021

Overview

Phase
Early Phase 1
Intervention
18F-T807
Conditions
Neurodegenerative Disorders
Sponsor
First Affiliated Hospital of Fujian Medical University
Enrollment
50
Locations
1
Primary Endpoint
standardized uptake value ratio (SUVR)
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.

Detailed Description

In this study, 18F-T807 (AV1451) molecular probe PET/CT was used to monitor the regional distribution and the degree of deposition in patients with neurodegenerative diseases, and compared with clinical symptoms to evaluate its value in the early differential diagnosis of neurodegenerative diseases.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaobo Yao, PhD

Director of Nuclear Medicine Department

First Affiliated Hospital of Fujian Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients or their families complain of significant memory impairment;
  • Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
  • Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
  • Signed written consent.

Exclusion Criteria

  • Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
  • Pregnancy or lactation.

Arms & Interventions

18F-T807, PET/CT

PET/CT perform after injecting 18F-T807

Intervention: 18F-T807

Outcomes

Primary Outcomes

standardized uptake value ratio (SUVR)

Time Frame: From right after tracer injection to 2-hours post-injection

the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

Aβ42 in CSF

Time Frame: Within 2 hours prior to tracer injection

Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with neurodegenerative diseases and is one of the biomarkers used clinically to diagnose neurodegenerative diseases

t-tau in CSF

Time Frame: Within 2 hours prior to tracer injection

t-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

NfL in the blood

Time Frame: Within 2 hours prior to tracer injection

NfL is significantly increased in the blood of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

NfL in CSF

Time Frame: Within 2 hours prior to tracer injection

NfL (neurofilament light chain) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

p-tau in CSF

Time Frame: Within 2 hours prior to tracer injection

p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration

Study Sites (1)

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