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

Neurodegenerative Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926259
• Other study ID #: MRCTA, ECFAH of FMU [2021]129
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2021
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Shaobo Yao, PhD
• Phone: 86-0591-87981618
• Email: yaoshaobo008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Neurodegenerative Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Aß42 in CSF	Aß42 (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
Primary	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
Primary	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
Primary	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
Primary	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