News | July 31, 2014

Data Supports Diagnostic Value of F-18 Flutemetamol in Early Onset Dementia

Study data presented at Alzheimer’s Association International Conference

July 31, 2014 — Study data presented at the Alzheimer’s Association International Conference in Copenhagen further demonstrates the diagnostic value of GE Healthcare’s investigational radiopharmaceutical product [18F]flutemetamol in confirming the presence of neuritic amyloid in those patients with early onset dementia. The data demonstrate that the use of [18F]flutemetamol increased diagnostic confidence for physicians, and in many patients, helped to confirm or exclude the diagnosis of Alzheimer’s disease and lead to changes in management.

“Early and accurate diagnoses may have implications for both prognosis and treatment among patients with early onset dementia,” said Dr. Marissa Zwan, VU University Medical Center, Amsterdam and lead investigator of the study. “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.”

Studies have shown that in early onset dementia, approximately one of three patients has an atypical clinical presentation, often making it challenging to diagnose Alzheimer’s disease, especially in its early phases. In this study, 80 patients with early onset dementia (younger than age 70), and with physician diagnostic confidence less than 90 percent, underwent [18F]flutemetamol positeon emission tomography (PET) scans, which were assessed as either amyloid positive or negative. Clinical diagnosis and diagnostic confidence was determined, both before and after disclosure of the scan results.

The data showed that 20 percent of patients had a change in diagnosis following review of the [18F]flutemetamol scan. In particular, for those patients diagnosed with Alzheimer’s disease prior to a [18F]flutemetamol scan and who had an amyloid negative result, clinical diagnosis changed in 12 of 15 patients. Overall, confidence in diagnosis significantly increased from 67(±12) percent to 90(±16) percent after disclosing PET results. Additionally, in 48 percent of patients, [18F]flutemetamol PET results led to a change in patient healthcare management (i.e. medication changes, additional care).

In October 2013, [18F]flutemetamol received approval from the U.S. Food and Drug Administration (FDA), where it is marketed as Vizamyl, for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. Vizamylis for diagnostic use only and should be used in conjunction with a clinical evaluation. Vizamyl is not licensed in any market for estimating the risk of MCI progression to clinical AD.

In June 2014, [18F]flutemetamol received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending the granting of a marketing authorization for PET imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive impairment. It is not yet approved for use in Europe or Japan

“These data demonstrate the diagnostic value of [18F]flutemetamol among those with early onset dementia and add to the growing body of evidence that it can help physicians identify the histopathology associated with an Alzheimer’s disease diagnosis in specific patients,” said Ger Brophy, Ph.D., chief technology officer, GE Healthcare Life Sciences. “If and when approved in the European Union,[18F]flutemetamol will be an important tool to support assessments of patients with cognitive disorders, including AD.”

The results of this study were presented orally by Zwan and as a poster at AAIC entitled “Clinical Impact of [18F]Flutemetamol PET in Young Onset Dementia.” The study was sponsored by GE Healthcare.

For more information: newsroom.gehealthcare.com

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