A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population
NCT05527288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-09-02
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.
Conditions
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
Interventions
- 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.
Sponsors & Collaborators
-
Sinotau Pharmaceutical Group
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-28
- Primary Completion
- 2021-09-12
- Completion
- 2021-09-12
Countries
- China
Study Locations
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