Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 500-1900 MBq/mL [13.5-51 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 -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimers disease (AD) and other causes of cognitive decline
- A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patients cognitive impairment is due to AD
- A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition
- Amyvid is an adjunct to other diagnostic evaluations.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Diagnosis: [(11)C]PIB and Na[(18)F]F tracers are effective in distinguishing transthyretin amyloidosis (ATTR) amyloidosis patients from controls and from those with cardiac light chain amyloidosis, while [(18)F]FBP is effective for diagnosing cardiac amyloidosis but ineffective in differentiating amyloid cardiomyopathy subtypes (ATTR-CM vs. cardiac light chain amyloidosis). Effectiveness evidence for [(18)F]FBB and [(18)F]FMM tracers remains contradictory.
- Alzheimer’s Disease (AD) Diagnosis and Mild Cognitive Impairment (MCI) Prediction: AD diagnosis has a high pooled sensitivity (0.90) and specificity (0.80) with a diagnostic odds ratio (DOR) of 35.68 and area under the curve (AUC) of 0.91. Subgroup analysis reveals high sensitivity (0.91) and specificity (0.81) for AD vs. normal controls, but low specificity (0.49) for AD vs. MCI differentiation, with moderate sensitivity (0.84) and specificity (0.62) for MCI conversion prediction.
- Tracer Comparison in Alzheimer’s Disease: [(11)C]PIB PET and [(18)F]FBP PET show no significant differences in diagnostic efficacy for AD, with consistent effectiveness across visual and quantitative assessment approaches.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Amyvid (florbetapir F 18) Prescribing Information. | 2023 | Eli Lilly and Company, Indianapolis, IN |
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 |
| Amyloid-beta PET in Alzheimer's disease: A systematic review and Bayesian meta-analysis | 2023 | Brain and Behavior |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| International Nuclear Medicine consensus on the clinical use of amyloid positron emission tomography in Alzheimer’s disease. | 2022 | Phenomics |
| ACR Appropriateness Criteria® Dementia | 2020 | Journal of the American College of Radiology |