GE Healthcare to present results of phase 2 study of flutemetamol at HAI Meeting

GE HealthcareApr 12 2010

GE Healthcare will today present results from its multicenter phase 2 study of flutemetamol at the 4th annual Human Amyloid Imaging (HAI) Meeting in Toronto, Canada. Flutemetamol is a positron emission tomography (PET) imaging agent in development by GE Healthcare, in the field of brain imaging.

The purpose of the phase 2 study was to investigate the efficacy of flutemetamol in differentiating between patients with clinically probable Alzheimer's disease (AD) and cognitively intact healthy volunteers (HVs). In the study, subjects with a high probability of amyloid (27 AD patients) and a low probability of amyloid (25 healthy subjects) underwent PET imaging with flutemetamol. Five independent image readers, each blinded to the patient diagnosis, separately decided if each subject's image was normal or abnormal. The accuracy of image assessments was determined by comparing them to the subjects' diagnoses. In addition, 20 subjects with a memory disorder known as mild cognitive impairment (MCI), which may represent early AD, were enrolled and imaged with flutemetamol.

"The availability of a tool such as [18F] Flutemetamol to identify amyloid in life could bring tremendous benefits to the field of Alzheimer's disease," said William E. Klunk, MD, PhD, Professor of Psychiatry and Neurology, University of Pittsburgh. "Increasing focus on the early diagnosis of this devastating disease and PET imaging might offer an opportunity to contribute to the knowledge base of the physician as we strive to progress novel treatment and management regimes for our patients."

The flutemetamol phase 3 trial program is a series of multicenter studies that include patients who consent to brain biopsy or to post-mortem assays to determine the level of association between imaging detection and histopathology findings, as well as patients with MCI who may progress to AD. The trials have already commenced with recruitment and imaging of patients at multiple sites in the USA and Europe.