Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926259
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Weibing Miao, PhD, 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.

Condition or disease Intervention/treatment Phase
Neurodegenerative Disorders Drug: 18F-T807 Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. standardized uptake value ratio (SUVR) [ Time Frame: 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

  2. Aβ42 in CSF [ Time Frame: 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

  3. t-tau in CSF [ Time Frame: 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

  4. p-tau in CSF [ Time Frame: 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

  5. NfL in CSF [ Time Frame: 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

  6. NfL in the blood [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926259


Contacts
Layout table for location contacts
Contact: Weibing Miao, MD 86-0591-87981618 miaoweibing@126.com
Contact: Shaobo Yao, MD 86-0591-87981619 yaoshaobo008@163.com

Locations
Layout table for location information
China, Fujian
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Weibing Miao, MD    059187981618    miaoweibing@126.com   
Contact: Shaobo Yao, MD    059187981619    yaoshaobo008@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Layout table for additonal information
Responsible Party: Weibing Miao, PhD, Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04926259    
Other Study ID Numbers: FirstAHFujian10
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurodegenerative Diseases
Nervous System Diseases