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A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population

Alzheimer Disease Clinical Trial

Official title:
Single-arm, Single-center, Non-randomized, Open-label Study on the Application of Amyloid Imaging Agent [18F]Florbetaben（18FBB） PET/CT Imaging to Distinguish Non-cognitively Impaired Subjects and Mild to Moderate Alzheimer Disease Subjects in Chinese Population

Clinical Trial Summary

This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with Alzheimer disease.

Clinical Trial Description

This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. The diagnostic efficacy of the visual and quantitative assessments of 18FBB PET images for diagnosis of Alzheimer disease will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. Imaging results were compared with reference standards to assess the ability of 18FBB PET imaging to differentiate non-cognitively impaired subjects from mild to moderate AD subjects. To investigate the pharmacokinetic characteristics of healthy subjects after single intravenous administration of 18FBB in Chinese population. Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05527288
Study type Interventional
Source Sinotau Pharmaceutical Group
Contact
Status Completed
Phase N/A
Start date January 28, 2021
Completion date September 12, 2021
View Details
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