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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurodegenerative Disorders

Intervention / Treatment
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* Drug: 18F-T807


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-T807, PET/CT<br>PET/CT perform after injecting 18F-T807 | Drug: 18F-T807<br>* 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.<br>|

What is the study measuring?
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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 |