PT  - JOURNAL ARTICLE
AU  - Senda, Michio
AU  - Miki, Takami
AU  - Shimada, Hiroyuki
AU  - Yamamoto, Yasuji
AU  - Kowa, Hisatomo
AU  - Kim, Jae Seung
AU  - Sugino, Masakazu
AU  - Sasaki, Masahiro
AU  - Oh, Seung-Jun
AU  - Sherwin, Paul
TI  - Efficacy of [<sup>18</sup>F]flutemetamol in the Japanese population
DP  - 2014 May 01
TA  - Journal of Nuclear Medicine
PG  - 1869--1869
VI  - 55
IP  - supplement 1
4099  - http://jnm.snmjournals.org/content/55/supplement_1/1869.short
4100  - http://jnm.snmjournals.org/content/55/supplement_1/1869.full
SO  - J Nucl Med2014 May 01; 55
AB  - 1869 Objectives Efficacy of [18F]flutemetamol as a brain β-amyloid imaging agent has been validated on Caucasians, but little has been reported on Japanese. Positivity and degree of amyloid deposit were investigated using [18F]flutemetamol-based PET scans on Japanese subjects with probable Alzheimer’s disease (pAD), amnestic mild cognitive impairment (aMCI) and healthy volunteers (HVs), together with inter-reader agreement and test-retest reproducibility. Methods 20 subjects with pAD, 20 subjects with aMCI and 25 HVs underwent a 30min PET scan starting 90min post injection of 185MBq of [18F]flutemetamol. Additional 5 pAD subjects underwent two PET scans less than 4 weeks apart, to evaluate test-retest variability. Blinded visual image reads by independent board-certified readers were compared with the subject’s clinical diagnoses and with composite cortical standardized uptake value ratios (SUVR) using cerebellar cortex as the reference region. Inter-reader agreement was assessed for 5 Japanese and for 5 non-Japanese readers. Results Clinical diagnoses and the blinded reads were highly associated, with positive rate of 23/25 for pAD, 10/20 for aMCI and 1/25 for HV. SUVR (mean±SD) was 2.05±0.42 for pAD, 1.61±0.30 for aMCI, and 1.20 ±0.09 for HV. There was good agreement between SUVR and blinded reads, and the PET images allowed differentiation between pAD subjects and HVs. The kappa statistic for inter-reader agreement was 0.94 and 0.96 for 5 Japanese readers and for 5 non-Japanese readers, respectively. The mean test-retest variability of SUVR ranged from 1.85% to 2.27% across all cortical regions. Test-retest agreement of the blinded reads was 100% for all readers. Conclusions [18F]flutemetamol is a robust tracer with qualitative and quantitative reproducibility and is useful for in vivo detection of increased brain β-amyloid load for the Japanese population. Research Support This study is the phase-II clinical trial (GE067-017) sponsored by GE Healthcare.