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

Neurodegenerative Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344845
• Other study ID #: PUMCH-NM-PBB3
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Peking Union Medical College Hospital
• Contact: Chenhao Jia, M.D.
• Phone: 86+18548703382
• Email: jiachenhao24[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 49 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Diagnostic Test:
• 18F-PBB3 PET/CT scan
Patients with suspected neurodegeneration underwent PET/CT scan after injection of 370MBq (10 mCi)18F-FDG to observe for TAU deposition.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Performance	Diagnostic performance including sensitivity, specificity, accuracy	Through study completion, an average of 1 year
Secondary	Clinical Stage	Clinical stage changed by 18F-PBB3 PET/CT compared to 18F-FDG PET/CT.	Through study completion, an average of 1 year