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A new radioactive diagnostic agent tailored for use with positron emission tomography (PET) imaging of the brain in adults is presently being assessed for Alzheimerís disease (AD) and dementia has been approved for use in the United States.

Dementia is linked with failing brain functions such as judgment, memory, language, and complex motor skills. The dementia caused by AD is associated to the buildup in the brain of an abnormal protein called beta amyloid and can cause damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in elderly individuals without neurologic disorders.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted approved to Vizamyl (flutemetamol F18 injection), which operates by fastening to beta amyloid and generatingg a PET image of the brain that is used to evaluate the existence of beta amyloid.

A negative Vizamyl scan revealas that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to AD. A positive scan means that there is most likely a temperate or greater amount of amyloid in the brain, but it does not determine a diagnosis of AD or other dementia. Vizamyl does not replace other diagnostic tests used in the assessment of AD and dementia.fda approves brain imaging agent

ďMany Americans are evaluated every year to determine the cause of diminishing neurologic functions, such as memory and judgment, that raise the possibility of Alzheimerís disease. Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD and dementia,Ē said deputy director of the Office of Drug Evaluation IV in the FDAís Center for Drug Evaluation and Research, Shaw Chen, MD.

Vizamyl is the second diagnostic drug currently available for visualizing beta amyloid on a PET scan of the brain. In 2012, the FDA approved Amyvid (Florbetapir F18 injection) to help assess adults for AD and other causes of cognitive deterioration. Vizamylís effectiveness was confirmed in two clinical studies consisting of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and were scanned. The images were interpreted by five independent readers devoid to all clinical information. A segment of scan results were also verified by autopsy.

The studyís findings certified that Vizamyl exactly detects beta amyloid in the brain. The results also confirm that the scans are reproducible and trained readers can precisely interpret the scans. Vizamylís safety was established in a total of 761 participants.

Vizamyl is produced for General Electric (GE) Healthcare (Chalfont St. Giles, UK) by Medi-Physics, Inc. (Arlington Heights, IL, USA).††


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