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

Primary Purpose

Neurodegenerative Disorders

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

18F-T807

About this trial

This is an interventional diagnostic trial for Neurodegenerative Disorders

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-T807, PET/CT

Arm Description

PET/CT perform after injecting 18F-T807

Outcomes

Primary Outcome Measures

standardized uptake value ratio (SUVR)

the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04926259

First Posted

June 7, 2021

Last Updated

November 23, 2021

Sponsor

First Affiliated Hospital of Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04926259

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodegenerative Disorders

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-T807, PET/CT

Arm Type

Experimental

Arm Description

PET/CT perform after injecting 18F-T807

Intervention Type

Drug

Intervention Name(s)

18F-T807

Intervention Description

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.

Primary Outcome Measure Information:

Title

standardized uptake value ratio (SUVR)

Description

the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

Time Frame

From right after tracer injection to 2-hours post-injection

Title

Aβ42 in CSF

Description

Time Frame