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Clinical Trials/NCT06344845
NCT06344845
Recruiting
Not Applicable

Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases

Peking Union Medical College Hospital1 site in 1 country80 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodegenerative Diseases
Sponsor
Peking Union Medical College Hospital
Enrollment
80
Locations
1
Primary Endpoint
Diagnostic Performance
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through [18F]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of [11C]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
November 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Between 45 and 90 years old; No gender limitation. Brain MRI supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases.
  • Informed consent signed in person by the subject or his legal guardian or caregiver.

Exclusion Criteria

  • Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases.
  • Received an experimental drug or device within 1 month (whose efficacy or safety is unclear).
  • patients who were unwilling to undergo PET/CT scans. pregnancy.

Outcomes

Primary Outcomes

Diagnostic Performance

Time Frame: Through study completion, an average of 1 year

Diagnostic performance including sensitivity, specificity, accuracy

Secondary Outcomes

  • Clinical Stage(Through study completion, an average of 1 year)

Study Sites (1)

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