Summary

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• Amyvid (florbetapir F 18) is 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. 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 patient’s 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.
• This summary is based on the review of two systematic review(s)/meta-analysis(es). ^[1-2]
• Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Diagnostic accuracy for differentiating AD from normal controls shows a pooled sensitivity of 0.91 and specificity of 0.81. Differentiation of AD from MCI reveals a much lower specificity of 0.49, indicating potential diagnostic challenges in this subgroup.
• Transthyretin (ATTR) Amyloidosis and Cardiac Involvement: Diagnostic utility of [¹¹C]PIB and Na[¹⁸F]F tracers effectively differentiates ATTR-CM from cardiac light chain amyloidosis, while [¹⁸F]FBP is not effective for this purpose.
• There is no safety information available in the reviewed studies.
• High diagnostic sensitivity and specificity are observed in the general population for Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI), but specificity is poor for differentiating AD from MCI, which may affect accurate prediction of MCI conversion to AD. In ATTR amyloidosis, [¹¹C]PIB and Na[¹⁸F]F effectively diagnose the condition, with varying effectiveness in distinguishing between ATTR-CM and cardiac light chain amyloidosis.