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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodegenerative Disorders
• Intervention / Treatment: Drug: 18F-T807

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shaobo Yao, PhD; Phone Number: 86-0591-87981618; Email: yaoshaobo008@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Shaobo Yao, PhD; Phone Number: 059187981618; Email: yaoshaobo008@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
standardized uptake value ratio (SUVR)	the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference	From right after tracer injection to 2-hours post-injection
Aβ42 in CSF	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	Within 2 hours prior to tracer injection
t-tau in CSF	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	Within 2 hours prior to tracer injection
p-tau in CSF	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	Within 2 hours prior to tracer injection
NfL in CSF	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	Within 2 hours prior to tracer injection
NfL in the blood	NfL is significantly increased in the blood of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration	Within 2 hours prior to tracer injection

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: MRCTA, ECFAH of FMU [2021]129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No