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

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04926259
Collaborator
(none)
50
1
1
37
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-T807, PET/CT

PET/CT perform after injecting 18F-T807

Drug: 18F-T807
Intravenous injection of one dose of 10mCi (370MBq, ±5%) 18F-T807. Each subject receive a single intravenous injection of 18F-T807, and undergo PET/CT imaging within the specificed time.

Outcome Measures

Primary Outcome Measures

  1. standardized uptake value ratio (SUVR) [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

  2. Aβ42 in CSF [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

  3. t-tau in CSF [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

  4. p-tau in CSF [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

  5. NfL in CSF [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

  6. NfL in the blood [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005

Sponsors and Collaborators

  • First Affiliated Hospital of Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaobo Yao, PhD, Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier:
NCT04926259
Other Study ID Numbers:
  • MRCTA, ECFAH of FMU [2021]129
First Posted:
Jun 15, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021