Comparison of PET Amyloid Imaging in Japanese and Western Subjects
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
This was a Phase 2, multicenter study to assess the extent and patterns of [18F] flutemetamol
uptake in the brains of 3 groups of Japanese subjects: healthy volunteers (HV), amnestic mild
cognitive impairment (aMCI), and probable Alzheimer's disease (pAD), and to assess the
reproducibility of brain uptake and of image interpretation. Subjects underwent open-label
intravenous (i.v.) administration of Flutemetamol F 18 Injection and Positron emission
tomography (PET) imaging of the brain. Blinded visual image reads were performed by 10
independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine
image interpretation experience. The blinded visual assessments were compared with the
subject's clinical diagnoses, and the agreement between the image interpretations made by the
2 groups of readers (Japanese and non-Japanese) was determined.