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

Early Phase 1

Recruiting

• Conditions: Neurodegenerative Disorders
• Interventions: Drug: 18F-T807

• Registration Number: NCT04926259
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-12
• Study First Posted: 2021-06-15
• Status Verified: 2021-11
• Study Start: 2021-11-01
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-T807, PET/CT	18F-T807	PET/CT perform after injecting 18F-T807

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China