GE Healthcare of Chalfont St. Giles, U.K., said results from a multicenter phase II study of its PET imaging agent flutemetamol for brain imaging look promising.
The purpose of the study is to investigate the efficacy of flutemetamol in differentiating between patients with clinically probable Alzheimer's disease and cognitively healthy volunteers. Details were presented April 9 at the Human Amyloid Imaging (HAI) meeting in Toronto.
Twenty-seven subjects with a high probability of amyloid and 25 healthy subjects with a low probability underwent PET imaging with flutemetamol. Five independent image readers blinded to patients' diagnoses separately evaluated each subject's image as normal or abnormal. The accuracy of image assessments was determined by comparing them to the subjects' diagnoses.
In addition, 20 subjects with mild cognitive impairment, which may represent early Alzheimer's disease, were enrolled and imaged with flutemetamol.
Phase III of the trial program consists of a series of multicenter studies in the U.S. and Europe. Recruitment and imaging have begun for patients who consent to brain biopsy or to postmortem assays to determine the level of association between imaging detection and histopathology findings, as well as for patients with mild cognitive impairment who may progress to Alzheimer's disease.
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