New Study Shows Florbetapir F 18 Injection Scans Led to Change in Diagnosis and Management of Patients Being Evaluated for Cognitive Decline

Eli Lilly and Avid Radiopharmaceuticals a wholly owned subsidiary of Lilly, have announced new data showing that knowledge of amyloid status as determined by Florbetapir F 18 Injection imaging altered diagnosis and management in the majority of patients being studied. This is the first study to look at the impact of amyloid imaging on diagnosis and actual patient management using a randomized, controlled prospective design. These findings were presented at the Alzheimer's Association International Conference 2015 (AAIC) in Washington, DC.

The presence of beta-amyloid neuritic plaque in the brain may provide additional information to supplement a physician's clinical assessment of a patient with cognitive impairment. However, a negative beta-amyloid imaging scan indicates sparse to no plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's disease and reduces the likelihood that a patient's cognitive impairment is due to the disease.  It is important to note that errors may occur during image interpretation. Also, a positive scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorders and a negative scan does not preclude the development of brain amyloid in the future.

"These study results are the first to suggest in a controlled study that adding florbetapir to the diagnostic evaluation changed actual patient diagnosis and management by physicians who regularly manage this complicated and devastating disease," said Michael Pontecorvo, vice president, clinical development, Avid Radiopharmaceuticals. "Alzheimer's disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. These findings provide further support for how knowledge of the presence or absence of amyloid pathology may affect both diagnosis and management in patients being evaluated for Alzheimer's disease or other possible causes of cognitive decline."

In addition to altering patient diagnosis, results showed that knowledge of amyloid status as determined by florbetapir imaging changed patient management in the majority of study patients, particularly Alzheimer's disease medications (cholinesterase inhibitor use), in a direction consistent with amyloid status. The researchers found no group differences in cognitive performance or health outcomes at one year, and changes in medical history, psychotropic drug use, and psychiatric-related events were not significantly different between the immediate and delayed feedback groups. There was no evidence of increased safety risk associated with early disclosure of amyloid status.

These data add to a growing body of work that suggests knowledge of amyloid status may change intended and actual patient management.