title: An exploratory efficacy study of the amyloid imaging agent [(18)F]flutemetamol in Japanese Subjects.
abstract: OBJECTIVE
  The aim of the study presented was to investigate the brain uptake properties of the amyloid PET agent [(18)F]flutemetamol in Japanese healthy controls and clinically probable Alzheimer's disease (AD) patients, and to make a comparison with the results of a previously performed study on Caucasian subjects. [(18)F]flutemetamol was recently approved by the American Food and Drug Administration and the European Medicines Agency for visualization of amyloid in vivo. Since the first clinical study of [(18)F]flutemetamol-an (18)F derivative of the PET tracer 11C-Pittsburgh Compound B targeting β-amyloid--took place, several clinical studies have been performed, but few focusing on a Japanese population.
  
  
  METHODS
  In the Step A, three elderly healthy volunteers and three AD subjects underwent dynamic PET scanning 0-30 and 60-150 min after injection of 185 MBq [(18)F]flutemetamol. The brain volume of distribution (VT) was quantified using Logan's linear graphical analysis and as standardized uptake value ratios (SUVR) with a cerebellar reference. The optimal acquisition window was determined from brain time activity curves for Step B. In the Step B, 5 AD and 5 elderly healthy volunteers were scanned from 80 to 140 min after intravenous injection of [(18)F]flutemetamol. The data from the two parts were pooled for estimation of overall efficacy.
  
  
  RESULTS
  [(18)F]Flutemetamol injection was shown to be safe-no serious adverse events were reported during this study. A simplified SUVR estimate of the uptake of [(18)F]flutemetamol using a time window of 85-115 min post injection successfully discriminated AD cases from healthy volunteers. AD subjects showed an elevated tracer uptake in prefrontal cortex, the lateral temporal cortex and precuneus amongst other regions. No significant [(18)F]flutemetamol PET differences could be seen between the Japanese AD cases in this study and those from an earlier Caucasian study, or between control subjects in Japanese and Caucasian studies.
  
  
  CONCLUSIONS
  This study supports the use of [(18)F]flutemetamol PET in Japanese population as a marker of the presence of fibrillar β-amyloid. The lack of differences between the Japanese cohort and those from a previous Caucasian cohort supports the extrapolation of results from other Caucasian [(18)F]flutemetamol PET studies to the Japanese population.
authors: Division of Molecular Imaging, Institute of Biomedical Research and Innovation, Kobe, Japan.
authors: Michio
authors: M
authors: Senda
authors: Yasuji
authors: Y
authors: Yamamoto
authors: Masahiro
authors: M
authors: Sasaki
authors: Tomohiko
authors: T
authors: Yamane
authors: David J
authors: DJ
authors: Brooks
authors: Gill
authors: G
authors: Farrar
authors: Brian
authors: B
authors: McParland
authors: Kerstin
authors: K
authors: Heurling
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000000981:diagnostic imaging / Q000378:metabolism; D016229:Amyloid beta-Peptides / Q000378:metabolism*; D000814:Aniline Compounds / Q000009:adverse effects; D044466:Asian People; D052160:Benzothiazoles / Q000009:adverse effects; D001921:Brain / Q000000981:diagnostic imaging* / Q000378:metabolism; D001931:Brain Mapping / Q000379:methods; D015331:Cohort Studies; D005260:Female; D005462:Fluorine Radioisotopes / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D049268:Positron-Emission Tomography / Q000009:adverse effects / Q000379:methods*; D019275:Radiopharmaceuticals / Q000009:adverse effects; D013997:Time Factors
chemical_list: D016229:Amyloid beta-Peptides; D000814:Aniline Compounds; D052160:Benzothiazoles; D005462:Fluorine Radioisotopes; D019275:Radiopharmaceuticals; C581552:flutemetamol