AAIC: F-18 Flute shown to change management in 20% of dementia patients

The amyloid PET agent F-18 flutemetamol (Vizamyl) was the topic of two scientific sessions at the Alzheimer’s Association International Conference (AAIC), which concluded yesterday in Copenhagen. Results of one study showed how patients with mild cognitive impairment (MCI) whose scans were positive for flutemetamol were 2.5 times more likely to progress to Alzheimer's disease. Another study of early onset dementia patients showed improvements in clinical decision making and clinician confidence as a result of information gleaned from flutemetamol PET.

David A. Wolk, MD, associate professor of neurology and assistant director of the Penn Memory Center and University of Pennsylvania Health System, and colleagues authored the first referenced study. “Our data, similar to other trials which have examined the potential role of beta amyloid in MCI, indicate that such studies may help in stratifying the risk for development of dementia in this population,” Wolk told Molecular Imaging. "“This prognostic information may have clinical value for patients and families, but will obviously become of much greater significance with the emergence of disease-modifying agents in earlier stages of disease."

In the second study, researchers including Marissa Zwan, a PHD candidate at VU University Medical Center, Amsterdam, sought to gauge the clinical benefit of the agent in patients with a diagnosis of early onset dementia. A total of 80 patients younger than 70 with a diagnosis of early onset dementia were included. These diagnoses had to have been made with less than 90 percent physician confidence. Each subject received F-18 flutemetamol PET imaging, which was then interpreted and physician confidence recorded.

Results showed that 20 percent of patients underwent a change in patient management such as an altered diagnosis as a result of PET imaging with the agent—and 48 percent of patients underwent a change in care of some kind, whether that be a different type of medication or some other form of healthcare. 

The most significant change in patient management occurred for the group of patients who had been diagnosed with Alzheimer’s but tested negative for amyloid pathology in the brain with flutemetamol. Clinical diagnosis changed in 12 out of these 15 patients. Physician confidence rose from about 67 percent to around 90 percent after results of PET imaging became clear.

“Early and accurate diagnoses may have implications for both prognosis and treatment among patients with early onset dementia,” said Zwan in an official statement. “Greater diagnostic confidence supports better patient management and helps physicians to determine appropriate treatment options, as well as helping patients and caregivers to plan for the future.”

F-18 flutemetamol was approved by the FDA in October 2013. The European Committee for Medicinal Products for Human Use (CHMP) provided a positive recommendation for European approval in June. A major coverage decision is expected in about three months’ time, estimated officials at GE, sponsors of the study.