Biomarkers

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ResearchersAgainstAlzheimer's would like to thank Roche Diagnostics for their support of this project.

Amyvid (florbetapir F18 injection)

Method of Measurement (Pre-analytical Tools)
Imaging
Biomarker Measured
Amyloid
Use
Diagnostic
Stage of Development
In use (FDA approved)
Active vs Completed Trials
Completed
Aim/Results

Amyvid is a radioactive diagnostic agent 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.

What is Required from Patients

injection of radioactive tracers, mild discomfort, in clinic visit

What is Required from the Health System

PET technician, PET scanner, dyes

Sponsor

Alzheimer’s Drug Discovery Foundation (ADDF); Eli Lilly

  1. “ALZHEIMER’S BIOMARKERS, EXPLAINED.” https://www.alzdiscovery.org/news-room/blog/alzheimers-biomarkers-explained

  2. Amyvid prescribing information. https://pi.lilly.com/us/amyvid-uspi.pdf

  3. “Drug Approval Package: Amyvid (Florbetapir F 18 Injection)”. U.S. Food & Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202008_Florbetapir_Orig1s000TOC.cfm

  4. “FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline.” https://www.prnewswire.com/news-releases/fda-approves-amyvid-florbetapir-f-18-injection-for-use-in-patients-being-evaluated-for-alzheimers-disease-and-other-causes-of-cognitive-decline-146638165.html