Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous: 50 to 5000 MBq/mL [1.4 to135 mCi/mL]) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.
Summary
- Florbetaben F 18 (Neuraceq) is used for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline.
- The information was derived from a single study that primarily focuses on the use of PET imaging in diagnosing, assessing disease progression, or treatment response and its relation to clinical outcome in follow-up of transthyretin amyloidosis patients.
- A total of 21 studies investigating five PET tracers were reviewed. Among these tracers, Neuraceq did not demonstrate superior effectiveness compared to others like [11C]PIB, [18F]FBP, and Na[18F]F in distinguishing ATTR amyloidosis patients from controls.
- However, it is important to note that this comparison does not directly relate to Neuraceq's indicated use for estimating β-amyloid neuritic plaque density related to Alzheimer’s Disease and cognitive decline, as the study focused more on ATTR amyloid cardiomyopathy cases.
- No direct safety comparisons between Neuraceq and other tracers within the context of Alzheimer’s Disease were provided by this study. It suggests variability exists among different types of tracer appropriateness based on specific clinical contexts, which should be considered.
- The study indirectly emphasizes patient-specific factors such as the type of amyloidosis during tracer selection but doesn't explicitly address subgroup considerations within the population suffering from cognitive decline or those being evaluated for Alzheimer's disease.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Neuraceq (florbetaben F 18) prescribing information. | 2023 | Life Molecular Imaging Ltd., Warwick, United Kingdom |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: a systematic review. | 2023 | European Journal of Nuclear Medicine and Molecular Imaging |