Updated Phase 2 Data With Flutemetamol Published in Annals of Neurology
PRINCETON, N.J., Sept. 7 /PRNewswire/ -- GE Healthcare announced today that results from its multicenter phase 2 study of flutemetamol were published in the September issue of Annals of Neurology. Flutemetamol is an investigational positron emission tomography (PET) imaging agent being developed 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). The primary endpoint was the efficacy of blinded assessments of flutemetamol binding to Beta-amyloid, the major constituent of amyloid plaque, which is a pathological hallmark of AD. 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 subject's clinical status, separately decided if each subject's image corresponded to normal or raised amyloid levels. The accuracy of image assessments was determined by comparing them to the subjects' clinical diagnoses. In addition, 20 subjects with a memory disorder known as mild cognitive impairment (MCI), which may represent a pre-dementia stage of AD, were enrolled and imaged with flutemetamol.
The image readers found that scans from 25 of the 27 AD patients displayed elevated flutemetamol uptake, as did 1 of 15 HVs who were older than 55 years, corresponding to a sensitivity of 93.1% and a specificity of 93.3% against their clinical diagnoses. In the group with MCI, visual inspection revealed raised binding of flutemetamol in 9 of 20 subjects. Test-retest reliability was very high when subjects underwent repeat scanning after 7 days. Additionally, comparable uptake ratios were seen when compared to 11CPIB of which flutemetamol is an analog.
"These data show that flutemetamol ex