Comparison of PET Amyloid Imaging in Japanese and Western Subjects

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.

Timeline

Start

2012-10

Primary completion

2013-05

Completion

2013-05

Publications

• Miki T, Shimada H, Kim JS, Yamamoto Y, Sugino M, Kowa H, Heurling K, Zanette M, Sherwin PF, Senda M. Brain uptake and safety of Flutemetamol F 18 injection in Japanese subjects with probable Alzheimer's disease, subjects with amnestic mild cognitive impairment and healthy volunteers. Ann Nucl Med. 2017 Apr;31(3):260-272. doi: 10.1007/s12149-017-1154-7. Epub 2017 Feb 8.

Drugs

Indications