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New Study Shows Beta-Amyloid Imaging is Associated with Altered Diagnosis and Management of Alzheimer's Disease
Date:7/16/2014

ient's cognitive impairment is due to AD. A positive florbetapir F 18 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. Florbetapir F 18 is an adjunct to other diagnostic evaluations.

Limitations of Use:

  • A positive florbetapir F 18 scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness of florbetapir F 18 have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring responses to therapies

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the florbetapir F 18 estimation of brain neuritic plaque density during image interpretation
  • Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of florbetapir F 18 images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the florbetapir F 18 scan as well as motion artifacts that distort the image
  • Florbetapir F 18 scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future

Radiation Risk

  • Florbetapir F 18, similar to other radiopharmaceuticals, contributes to a patient's overall long‐term cumulative radiation e
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SOURCE Eli Lilly and Company
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