Trials / Completed
CompletedNCT05527288
A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sinotau Pharmaceutical Group · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug: [18F]florbetaben | All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq. |
Timeline
- Start date
- 2021-01-28
- Primary completion
- 2021-09-12
- Completion
- 2021-09-12
- First posted
- 2022-09-02
- Last updated
- 2022-09-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05527288. Inclusion in this directory is not an endorsement.