Amyvid (Florbetapir F 18 Injection), a medication for PET (Positron Emission Tomography) brain scans of adults, which estimates brain amyloid plaque content in patients with cognitive decline, has been approved by the Food and Drug Administration. Cognitive decline occurs when the patient finds it harder to think and form clear, rational thoughts, as well as making decisions. The person can eventually lose touch with what is real, himself/herself, others, and external events and surroundings.

With Amyvid, clinicians can detect Alzheimer's disease earlier on, as well as accurately identifying patients with early signs of memory impairments. Amyvid is a radioactive agent that tags β-amyloid proteins (clumps of a sticky substance), the hallmarks of Alzheimer's disease. The protein is detected using PET scans. β-amyloid protein also forms in some other cognitive disorders.
  • A negative scan - if few or no amyloid plaques (neuritic plaques) are detected, it is less likely that the patient's cognitive decline is Alzheimer's related.

  • A positive scan - moderate to frequent plaques are detected. Patients are more likely to have Alzheimer's disease, and also some other kinds of cognitive impairment. A positive scan may also come back in patients with normal cognition. The FDA stresses that a positive scan does not necessarily mean the patient has Alzheimer's disease, but all those with AD (Alzheimer's disease) have higher plaque content.
Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, said:

"Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning. Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy.

This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations."

R. Edward Coleman, M.D., professor of radiology, Duke University Medical Center, said:

"Florbetapir gives patients with cognitive decline, their families and the physicians who treat them, more information about the amyloid plaques that may be found in their brain. This approval marks a great advancement in nuclear medicine practice, as it enables us to evaluate the presence or absence of moderate to frequent levels of amyloid plaques in a patient's brain.

In conjunction with other tests, florbetapir may help give physicians additional information when evaluating patients for the cause of their cognitive decline."

An Amyvid PET scan does not predict AD development, or other associated dementia development; neither is it used for monitoring how patients respond to treatments. The FDA adds that Amyvid is not a substitute for existing diagnostic tests utilized when evaluating cognition.

Adverse reactions linked to Amyvid usage include nausea, fatigue, musculoskeletal pain, and headache.

Amyvid is made by Avid Radiopharmaceuticals (owned by Eli Lilly and Company), Philadelphia, USA.

Written by Christian Nordqvist