審議結果報告書 - 医薬品医療機器総合機構
Contents
1. PET2. lt gt ISO 14971 Ties gt fe lt gt
3. Q 1 ALZ103 1 2 100 MBq 4 150 MBq 6 7 21 Ei 6 37 3 S1 7 0 0324 mSv MBq 0 429 MBq h MBq 0 287 MBq h MBq 0 287mGy MBq
4. PET PET ali all
5. OR CH 7 GR 3 gt qu Um lt
6. 2 2 F D I SF FDG 23 4E 12 1 22300BZX00445000 PET F
7. F FDG AD AB NO 1 2 3 d 1 PET AD AB
8. GEO67 021 GE067 007 GE067 015 7 uH 3
9. 27 4 2 1 3 10 1 FASTIab GE 26 3 20 e r rbpG SF FDG
10. 2 lt gt gt lt gt 7
11. 10 gr 95 10 95 EI T PET PET PET
12. 4 lt gt GCP gt GCP 5
13. 40 100 B AB Pittsburgh Compound B 2 4 methylamino phenyl 1 3 benzothiazol 6 ol PiB 2 AB PET RB 1 1 F
14. 1 GE067 014 60 ER 370 MBq ALZ201 B 4 a 120 MBq 185 MBq 17 4 GE067 ail FE vg 370 MBq nr NE 21751505
15. VOIJ 2 VOI ROI VOI E 10 8 Was E 23 10
16. 22 0 G 0 X OTERRIAS ER EG TESI wc EB PRI BITE OD BRL CH SER p IS zyuct Eg gt 8 PE AER T 46 27 2 27 2 PET PET 7 gt 8
17. GE067 014 ALZ103 2 60 90 2 prd H TR H A LM pM JR ALZ103 E 89 7 95 9 ALZ103 0 0324 mSvyMBq GE067 014 ALZ103 GE067 014
18. gt 7 1 1 10 1 20 2
19. MMSE 27 50 AD National Institute of Neurological and Communicative Disorders and Stroke Alzheimer s Disease and Related Disorders Association NINCDS ADRDA probable AD Diagnostic and Statistical Manual of Mental Disorders 4 edition IDSM IV AD MMSE 18 26 Clinical Dementia Rating CDR 0 5 1 2 50 1 3 14 AD 8 uoo 22 4 5 1 22 2 AD 1 s
20. S re 8 SOS e 2 MT T 38 GE067 015 CERT 70 80 E AB PET 2 GE067 015 KH GE067 007 125 14 L2 49 GE067 013 PET
21. 2008 9 2011 3 st 70 AD 25 ffl EB Pom aMCI 20 AD 7 1 185 MBq 238 Zl 120 MBq 238 2 2 x H3 PET 90 120 90 120 2 AD aMCI A 370 MBq 5 8 PET ij 1 4 PET C PiB 40 70 f
22. 70 DSM 80 80 amp IILTHSXS8 GE067 015 GE067 007 PET 2 5 AB a H Hr if h 22 BHO RU 2 D bx dl Ft RAT fL c5 AD 99 4 GE067 007
23. JC ES Er dA In F florbetapirr AD AD AD PET AB 38 3 PET AD Eg
24. I GEO67 017 PI a 10 s Erg A 10 9 Y 30 GE067 005 E s b pe gold standard 1 30 d jo GE067 005 GE067 021 017 40 GE067 017 SH ELA HOUR TT
25. Wachs ud 27 3 18 27 3 18 MM lt gt pH F
26. 49 23 24 1 25 3 Alzheimer s Disease International World Alzheimer Report 2009 http www alz co uk research files World Alzheimer Report pdf accessed September 30 2009 Ikonomovic M D et al Post mortem correlates of in vivo PiB PET amyloid imaging in a typical case of Alzheimer s disease Brain 2008 131 1630 45 ICHM7 DNA Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Sprague D R et al Human biodistribution and radiation dosimetry of the tachykinin NK1 antagonist radioligand 5F SPA RQ comparison of thin slice bisected and 2 dimensional planar image analysis J Nucl Med 2007
27. AD MCI 2 54 Linear fit a y x 2j y 0 987x 0 0084 S R2 0 8192 un ea 1 54 9 2 9 11 0 5 01 T T T T T T T T T T T T T T T T T T T T T T T T T 0 0 5 0 1 5 2 2 5 3 I8F flutemetamol SUVR 4 C PiB SUVR CER 9 7 7 72 2 4 2 Q 72 AD fiE 1 3 6 GE067 007 2010 6 H 2011 i 11 gt 203 CERAM
28. E in PET 1 PET AU PET 45 zm HX b o V p Eo ag 3 PET 1 PET goose iz Amo EX
29. 4 gt AB X Je 17 PET AB 3 lt gt 1
30. ye B f Ze gt m gp c s oves d E 3 E B AD
31. T ris 185 MBq I 4H 30 s Ei ALZ103 ftr k IL PET HI 185 MBq 185 MBq 30 x de CR OT 42 El rz 20 GE067 021
32. GE067 017 ALZ201 SUVR AD SUVR AD PET GEO67 007 7s 3
33. F florbetapir AB AD 2 2 082r 2372 38 4 E SE AB AD AD AD PET M 2 GEO67 007 GE067 015
34. H RR PR 0 9 9 3 ug kg 240 240 0 9 ng kg 3 PR 4 0 6 5 ms QT 2 9 ng kg 10 9 3 pg kg 5 10 QTcF 0 9 2 9 9 3 ug kg 10 3 QTcQ 0 9 02 9 ng kg 10 9 3 ug kg 1 2 5 10 QT QTcF QTcQ
35. 0 7 15 ug kg n 4 12 2 2 H 2 14 ng kg 15 ug kg js 3 1 32 34 37 L5178Y DNA TA98 S9
36. A AB 2 HS GEO67 014 I ALZ103 GEO67 017 1 PET AB AD AB AD AD AB PET
37. 90 110 120 MBq 370 MBq Opt 3 Y In M sk 2 9 AD 185 MBq 30 ME MBq 8 f f 1 nu IRIS Ze 20 GE067 007 j E 110 110 130
38. SUVR SUVR GE067 017 ALZ201 9 SUVR aMCI AD uu 9 ALZ201 GE067 017 ALZ201 GE067 017 E RD p 0 n 25 88 92 EUN 50 ELA E SE n 969 10096 n 25 92 96 96 4
39. nm 1 2 1 41 NZW 3 pg mL 0 1 mL 1 24 48 72 n 1 2 5 QD 5 GEH121132 GEH121133 GEH121015 GEH111832 GEH121280 gt 1 24 6 11 0611 1 2 2
40. in vitro P450 CYP CYP 2 20 60 97 8 75 2 2 4 3 3 13 21 n 3 240 Bf HZ E f E 3 19 E 6 0D amp DbIc 7v 470v 84H WRE E AUC O 10 20 E
41. 95 ERSH 70 GEO67 017 EA ps BH Js f 86 37 43 74 99 7999 23 29 95 PET AJ 959 3 8 95 37 39 9 GEO67 007 10 0 7770 0 9 180 E L 3E H e t
42. T E D TUR 95 CI 95 CI 95 CI 95 CI 23 6 29 2 37 39 25 43 68 BSS CT 8675 9256 9596 7995 72 9595 74 9975 83 9975 60 9275 5 096 9 180 2 1 1 Q 180 69 2 1 23 808 728 1
43. PET Ed 5 E um a ag Ce n tL Sit e I B cus iB Rl Hj dud PS zu m a f uu 3 3 RS IE PX OE HI pote
44. Tvf HASUHEr Hv BUADA TZDM EJ AD AD AB Q PiB 1 8 PiB PET PiB PiB H LH
45. 70 110 SF 185 MBq 120 MBq 370 MBq 3 110 185 MBq SF E 90 20 44 x Ax H iG p 70 7
46. IR ROI VOI gt Fili 2 HV GE067 014 ALZ103 AD F pAD AD HV UR BUR 3 ROI 3 1 GE067 014
47. 185 MBq PET 370 MBq x P ES Ed E PET PS 70 90 90
48. 1 ALZ103 ALZ201 1 I USTED E B f TI GE067 015 PET Bir RO 3 u ZA T GE067 014 4 GE067 017 F E AB E GEO67 007 GE067 007 Eram
49. s 959 48 7 PET 1 2 7 es 36 I fH GE067 014 I JH ALZ103 F
50. 15 28 Eg HU E d Ir3 CDU As GE067 10 gold standard TE 28 gold standard me GE067 007 GE067 015 D GEO67 021 GE067 007 GE067 015
51. PES E ER 20 amp 185 MBq 185 MBq 20 017 120 MBq 2 120 MBq m
52. 0 012 mGy MBq 0 012 mGy MBq 0 032 mSv MBq 0 026 0 045 0 026 mSv MBq 0 023 0 030 3 1 ALZ103 T GE067 014 O GE067 014 Decay Corrected and Dose Normalised 8F Plas
53. 47 F florbetapir Am Se PET AD AD 1 PET E AD E AB AD AB F florbetapirr PET F forbetapir
54. gt 1 AD 39 43 AB AB 8 AB AD AB AB F PET F 110 PET nn
55. H OB STIS 9 2 Hi mk H 6 ng mL EA 10 mL 1 60 ug body TTC 1 gt 1 120 ug H 20 ug TTC9
56. SEES EL BUR 3 Hx EE 3 CT 44 56 ELA HU E 3 A E gt mu E pe HL 2 3 Bm 5 zi E p 5 PET zd B GE067 021
57. AD AD 1 PET AD AD AD 7 8S NINCDS FH PET AD zh AD z2l8 1 PET 1 N 34 MRI CT
58. ON GR X oC e SF FDG NM 3 e SF E A AE 23 SE doTU 2 RE 3
59. 2 27 4A to LU nb 10 1 FASTIab GE 26 3 20 iid H um
60. a B HE ER LC TR 2 PET T 3
61. 3 OB 38 AB AB 33 1 id 584055 fl AD 6
62. gt 1 in vitro CD 1 22 183 ng mL 37 C 1 3 97 3 97 9 i S9 in vitro 1 19 S9 16 ng mL 372C 3 N 2 AD CD 1 GE067 014 2 3 100 MBq 3 150 MBq 8 4 4 5 40 3
63. RH RH au C 18 15 30 C 18 AH111907 20 C C 6 25 C 10 C 24 9 28 3E 422
64. GE067 007 GE067 015 RI 4 11 1 2 TL 2 7 831 18 98 62 5 69 5X 83 12
65. GEH121015 i GEHI21015 22 2 19 0219 4 QCH M3 R2 SF FDG FDG
66. SUVR Probable AD n 25 2 236 0 3751 2 0662 0 38999 aMCI n 20 1 702 0 4754 1 6119 0 29747 55 n 10 1 175 0 0785 1 1348 0 05652 gt 55 n 15 1 373 0 2260 1 2379 0 08248 n 25 1 294 0 2048 1 1967 0 08846 PET GE067 007 Y a GE067 014 ALZ103 AD 37
67. E JV 0E 5 E F 120 ng E 1 E E 1i ME H invivo
68. F florbetapir F florbetapir d 2010 AB E AD AB E i ce mil Br MO AD PET 35 AB O STRASSE
69. 16 ng kg H 1 33 9 14 n 4 7 5 15 Hg kg 10 7 5 ug kg 1
70. H ICH E gt 0301 20 BE iH Eoo REI 5k 22 4
71. 1 3 94 5 95 3 3 In vitro 1 18 19 S9 WC 2 4 ng mL 37 2C 4 N Aroclor1234 S9 16 ng mL 372C S9 3 S9 3 S9 4 N 18 Q In vivo 1 27
72. PET pk 23 12 H 1 H m uu FR 27 4 H e x Ul jJ D see Er E B AB SER F FDG F 2 Nes A T TT
73. 60 150 1107130 AD AD 90 70 110 70 90 2 185 MBq 43 p IEEE e 20 ze nj 370 MBq 30 S3 5 zyuc RBX AE
74. p net gt Es 8 s
75. Ede IS ZB JEFE 23 5 ER PET 120 MBq 90 120 MMSE 27 CDR 27 30 2 AD MMSE 15 26 CDR 0 5 1 2 55 tB 26 87 25 ELE HUS 17 70 AD 70 25 PET 1 PET E AE
76. PET AD PET AS X JE er pk PET NEPTIS plug 01 CK 2 pk e Xv 2 5Fflorbetapir X H 2012 AD E AD 238 c C doo een US Lj PET c Ji 5 AB OH
77. 1465 97 9 F S9 abi ie r d o AES E 1 2 41 fJ 1 H BM 2 ug TTC 120 ng f 8 240 3 Ex amp XYv5 07 05 fn
78. ICH QIB Q00Wh m gt M qd D HM E 41 3 lt gt 41 3 17 122 gt 2 4
79. XI kf i f E Iri MZ 5 PET 831 3f Fd
80. SoT E Ec I PE SUVR c Er 2 Hi 10D nu 50 11 5599 10 50 ET AA ER 10 LN Hm p Fleiss k 0 9379 8 ELA HJ E 4g f Z E 1 123 iU 2B H Ht c D js E93 x AD Jp Ne ES PET 3 9 45 10 50 9 4596 ECT 11 5599 HU
81. PET FO x 2 10 mSv 120 MBq GE067 007 37 0 MBq 10 0 120 MBq Ap
82. v 185 370 MBq EU XI Bi T v 0 145 55 Analysis Set FAS Kr PET KPyfe5 eA Xv R5 90 AB 27 120 23 f T 30 200 19 PET FE RAMEME AB 1 69 180 E PET
83. 50 PET 3 5 185 MBq PET MMSE 27 NINCDS ADRDA probable AD DSM IV AD MMSE 18 26 CDR 0 5 1 2 50 ru E Fd 1 fl 2 T D T 4 GEO67 017 8 209 9 7 2 a Bo AD Hep ta and 9 1 Q 22 3 AD 23 5 li 4p 14 AD
84. Hi 90 120 PPT iv aMCI AD 32 5 3 95 80 S 4 95 80 T 8 SoT
85. gt 1 2 30 90 8 3 1 7 21 7 2 2 20 60 23 8 12 0 0 0255 mSv MBq Cb TB I GEO67 014 74 9 30 902 84 7 SF E F uj KH
86. SA AD SU VR E 4 22 zi H Bc b in v VEA BUE AC EH SUVR Posterior Cingulate Cortex averaged over 60 to 90 minutes ll cE067 014 li ALZ 103 YA A INC X Is Hb D Wi Wm uH SUVR 6090 Gl 1 ALZ103 H pAD Ey 1
87. 94 aMCI GE067 005 1 80 80 80 83 831 10 94 2 07 831 1 11 831 1 011 831 1 8 831 1 8 831 97
88. 6 CN 6 CN PiB Pi BSIRALISVSC 6 CN Z27v X 2 EV E 6 CN PiB 6 CN SEO S FX6 CN PIBO BE rfr amp 8BS UL Cv 7 R220 93 6 CN AB R 0 88 6 CN PiB C PET DVR 6 CN PiB PiB C PET DVR R 0 31 R 0 98 2 3 E
89. 20 MBq 10 35 M ORARE C 38 vC ro iEn Xx H3 2 20 60 3 f E 1 2 3 2 2 3 H HH 2 20 60 E Ei 58 21 13 1 0 3 3 3 2 15 46 59 3 27 30 25 Q 3 4 1 13 0 4 2 7 MBq 8099233 109523 RR i lt LT M F gt 1
90. A PET 3 IL XH PET 48
91. PET GEO67 007 GE067 015 GBE067 007 PET GE067 015 PET GEO67 007 95 5 3 70 KO GE067 015 95 5 3 80
92. 2 9 7 3 mad hERG 1 11 hERG HEK293 0 7 ng mL E 4031 100 nM hERG n 4 hERG 7 7 3 2 E 4031 hERG 92 0 1 7 poco dd dco iu ris SD 6 7 PEOEHE 1 5 5 c ul I E Irwin Z 6 1 5 ng kg
93. 1 lt gt rH 1CH 0219 4 24 3 1 uil 1 I 12 lt acr PR ors A SE
94. AR 38 192 ug kg HER n 6 n 1 2 0 25 ibtd eR 2 1 32 WERE Wistar n 10 60 ug kg H L7 0 UR 15 30 60 ug kg H 27 ug kg Q 2 1 33
95. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use PET I PET 7
96. lt gt 8 gt 4 4142 zh lt gt gt dinis ix CE
97. 1 1 Ci4Hii FTN2OS 4 273 32 6 Benzothiazolol 2 3 F fluoro 4 methylamino phenyl 18 F HO S ot H N Me 18g 109 77 3 C o RAE BA OOX TTTI R IH
98. 2 100 aMCI 3 2 10 4 1 10 SUVR aMCI Dogs TH IX ER aMCI 27 A LH 50 SU VR CER AD ERE AERE MS AD II 3 ALZ201 aMCI C PiB j AD 1 1 1 1 aMCI E PS TS f
99. GE067 007 70 PET AD 0 5 PET 0 5 PET AB PET 2 PET Diagnostics and Statistical Manual of Mental Disorders DSM AD DSM 54 294 GBE067 007 DSM AD GE067 007 70
100. AD AD VIZAMYL 26 8 22 VIZAMYL AD AB PET VIZAMYL AD np uu
101. AD m E LE 3 39 zu E AB A PET E uu HU AA E ARC 5l GE067 015 f
102. m uu 70 74 92 94 6 Fleiss x 0 96 d 4 EH TUR d 96 T A Xj 3 E Bm ES E AD n 2 25 aMCI n 20 X55 nz 10 255 5 n 2 15 A positive 23 92 2 8 9 45 I1 5594 1 794 24 9694 negative 25 100 20 100 25 100 F1 RU ze EA mz 192 B positive negative 23 9294 2 8 9 4594 11 5594 9394 1 499 24 9694 i mL 25 10099 20 10094 10095 25 10094 positive 22 8894 9 4594 7 1 4 C negative 3 12 11 55 93 24 96
103. 11 GE067 015 2010 12 2011 3 p NA ROM qu ad Qin da 300 10 185 MBq 18 40 MMSE 28 MRI PET aMCI GE067 005 PET 3 218 181 PET AB AB
104. HU 20 Ps D 1 10 4 120 MBq 370 MBq E E TI 90 90 E E E 3 E Ht c5 E 185 E
105. NS AD AB Ex FH aH OE 14 733 0 47 AD PET s 158 np SP ADRDA SoT 11 92 AD EB insi B4
106. HL 1 t GE067 10 8 672 100
107. 1 41 E MRI HH T AB 1 T T PiB Cc C PiB C
108. Xx H3 IN VH pa Fi Z3 iu MMSE 27 CDR 0 25 aMCI Petersen aMCI i221 ER MMSE 27 30 CDR 0 0 5 55 AD NINCDS ADRDA 3 probable AD DSM IV AD MMSE 15 26 CDR 0 5 78 2 H 1 2 55 5o 5t B5B 20 25 1 AD 7 2 70 AD 25 E AB dx T EA E00 6 72
109. NI en ac OIN OEC 1 PET 2 pu E LU aon ETSI IE PET Ww s P4 EU
110. T EA HH Fi PET GE 26 3 20 FASTlab 1 ZEE TUETE EA FASTIab o H HX 1 2 2 FH D IB TH 22300BZX00443000
111. E sion v ik 25s n HC 1 DNA 3 EE 33 56 gt
112. PiB H AB PiB QD 1 9 14 20 H 1 4 0 9 2 9 9 3 ug kg 7 11 14 Snug kg 18 Q 4 0 9 ng kg 1 2 9 9 3 ng kg 1I
113. f I II ALZ201 AD XP SUVR AB 1 MY 11 PET 007 GE067 015 EO s
114. 03M U e SF FDG D sg Q 5 e SF 72 95 83 99 60 92 E St 92 23 25 Hr x En H Ee ON E 3 C Iv D AX TERS 500 7 7v zi A Nl 88 ELO Tb 2A mo
115. Wistar n 5 EE 7 H HY H e 2 2 3 1 Wc xu NEEME 27 14 ng kg 15 ug kg QUEE 60 kg Cf 0 33 ug kg 7 P 1 Vira 2
116. 2 68 2 GE067 007 Jp 3 44 3 44 EX arx LIE Bii xt 80 ZE GE067 007 AD PET GE067 007 f 1
117. 25 100 20 100 100 25 100 D positive 23 92 9 45 7 2 8 negative 2 8 11 5594 93 23 92 25 100 20 100 100 25 100 TEES positive 23 92 8 40 7 2 8 negative 2 8 12 60 93 23 92 25 100 20 100 100 25 100 IRA 23 92 9 45 1 7 1 4 2 8 11 55 14 93 24 96 AD AU 2 24 25 100 0 38 aMCI 1 70 0 48 C PiB SUVR CER x 20 10094 IRA 29 SUVR CER PET 4 RZ 0 82 15 100 5 3 A 25 10096 ri FE 1 28 0 20
118. 3 F2 i 19 CERAM SD f rH 1 29 ENEEEM 7577 572 PER NN N 7 IN lt E 45 EBURR VOU NN MEOS H E
119. ED 8 BESUM Thx CIC pas PET 88 22 25 92 23 25 i aMCI iod 7 3 ERI 2 Ls 8 Er HU j 9294 23 25 TE BERE D 9494 100 25 25 0 8756 1 0000 x A OVE EE 8 D BL pe Hn AES Ds OR Er 3A BUR Ii H 20
120. S9 DNA E 4 1 39 NZW 3 ug mL 0 3 mL B nm 1 2 1 40 NZW 3 pg mL 0 5 mL 4 1 24 48 72
121. 20 PET 110 PF PiB VIZAMYL 23 10 25 VIZAMYL AD AB PET AD
122. 46 831 6 2 17 831 1 8 831 1 30 SPE li z 4l m S
123. BE JE 3 HB 0 38 PET 150 tis 7 lt 3 49 AL
124. 176 107 FAS Full 69 1 1 68 PAS Post mortem Analysis Set Consortium to Establish a Registry for Alzheimer s Disease CERAD 1 5 SoT PET PET AB AB PET
125. H F florbetapir PET BSc xui PET ib QE 22600BZXx00279000
126. H F YN Ne 20 12 25 20 38 E 462 GO AD IX Ap BE AD x 65 7 Al E 1 WE ATTE h PALA Z HE L 1T SHE AD XX B AH AB f AD AD
127. D 9 e FI FI B 1 2 FASTIab PET
128. DA odvCv 5 LI E 200 702 C db 24 50 75 EIN fS Fr Ei AD CT AB
129. B 0 117 mGy MBq AK EE SUVR AD E BI EH SUVR 2 4 E 1 AD amp Ha EB D D x Ei 0 145 mGy MBq H E 0 399 MBq h MBq HL7EEE 5e F RE 3 3 185 MBq 0255 Bin
130. AD AD DSM III R DSM IV NINCDS ADRDA 10 ICD 10 0 AD AD AD AD N D
131. EN SoT por m mE T SE 06 95 5 CT SERIE 0 0 0 0 100 096 98 0 100 096 Lata 0 0 181 100 181 a 2 0 0 58 32 58 68 096 60 6 74 794 9 0 0 123 68 123 3 0 0 1 1 99 4 97 0 100 0 1 0 0 180 99 180 ERADE 4 0 0 1 1 1 99 494 97 096 100 096 S 0 0 180 99 180 zs Me Rp 0 0 2 1 2 98 994 96 1 99 995 B DA 5 NE E 0 0 179 99 179 m RETE 0 99 4 97 0 100 0 PEOR SoT 18 40 CI PET SUVR CER 1 12 0 097 14 9 Q7 81 C 5 5 5 10 181 3 9 77181 3 3 6 181
132. Q 1 1 ALZ103 2007 10 H 2008 3 H AD 22 1 3 1 2 100 MBq 4 150 MBq 6 PET CT 2 AD 3 185 MBq 25 AD amp 250 230 2 AD 1 3 1
133. 32 4 0 0255 mSv MBq EE TELE 0 520 MBq h MBq 0 398 MBq h MBq 0 201 MBq h MBq 0 114mGy MBq 0 0751 mGy MBq 0 0687 mGy MBq AD 3 3 18S MBq Standardized uptake values ratio SUVR AD SUVR
134. CD I 2 GE067 014 2011 2 2011 10 AD 22 2 3 1 3 100 MBq 3 150 MBq 24 PET CT 2 AD 3 185 MBq 0 30 60 150 PET PET 3 AD 5 185 MBq 75 1 PET 3
135. E7 in vitro 7 EOM xoi ERREUR GE ff 3 Zu HE ELA E 3 kt m CYP
136. e Te E 2 gt 1 QR 1 1 1 Hi uu d 1 1 28 29 31 SD 0 120 ug kg 1
137. 2 7 E X 4 2 8 Ef 10 FASTIab GE 26 8 20 HLT a En wm apm ull De ul n ia 27 4 28 3 51 fs 1 PET
138. 5 5 3 95 70 95 4 70 5 PAS SoT AE EE Lr N 43 N 25 95 CI 95 CT PRI SESESDIBSEGEGCSISESETSIISEJESISIBSENELS 1 8 19 22 88 35 81 3 12 43 25 8196 8896 67 9294 69 9894 mH N 4 ECT NN 1 5 12 23 92 88 929 2u a5 x 74 9695 74 9994 M N 4 r
139. CICER SCRIBAE AB H AD FA AS Ei iz HE Fi K AB HEERREEUL S A H mI E IFPR 6 41 ux H 4 L7 AD AD E
140. GE067 013 2 rupe EAS amp GE067 021 EB BUR 2 68 2 EH BUR PET jf E A Dv ic Em Lees Era HU Me E mL E PET 2 Erg A S i332 7
141. gt LN BS i 2 07 0 39 aMCI 1 61 0 30 SUVR CER AD EX ACH 1 20 0 09 10 096 7 70 1 1 Fleiss k 0 9622 0 9069 1 0000 Mai AD amp 92 100 Zu s i pe Di EH HU EH HU AM 96 H 9294 24 25 61 65 Cohen E 62 65 93 Cohen k E
142. 2 CD 1 13 04 2 7 MBq 2 20 60 90 120 2240 rn 5 6 2 He 30 6 10 8 23 0 5 3 s SHE 8 1 1 7 6 0 9 4 4 1 7 4 30 9 3 5 1 0 3 3 0 2 240 1 23 183 ng mL 37 C 1 3 97 0 97 3
143. 8 22 j mem 70 AD 1 185 MBq AD H PET A 25 pil Dis 5 aMCI aMCI 20 90 120 2 H 1 4 tt aMCI En AD f CR 0 25 Petersen aMCI MMSE CDR 0 0 5 55 NINCDS ADRDA probable AD DSM IV H EE kK 1
144. AD 2 2 27 aMCI PET aMCI 20 2 4 PET 5 PET SUVR CER PET 4 PET AB SoT PET C PiB PET IE A IRA 3 28 OH FRE
145. 48 1 100 7 Ch telat G et al Amyloid imaging in cognitively normal individuals at risk populations and preclinical Alzheimer s disease Neuroimage Clin 2013 2 356 65 7 Blacker D et al Reliability and validity of NINCDS ADRDA criteria for Alzheimer s disease The National Institute of Mental Health Genetics Initiative Arch Neurol 1994 51 12 1198 204 Jobst K A et al Accurate prediction of histologically confirmed Alzheimer s disease and the differential diagnosis of dementia the use of NINCDS ADRDA and DSM III R criteria SPECT X ray CT and Apo E4 in medial temporal lobe dementias Oxford Project to Investigate Memory and Aging Int Psychogeriatr 1998 10 3 271 302 Kazee A M et al Clinicopathologic correlates in Alzheimer disease assessment of clinical and pathologic diagnostic criteria Alzheimer Dis Assoc Disord 1993 7 3 152 64 Lim A et al Clinico neuropathological correlation of Alzheimer s disease in a community based case series J Am Geriatr Soc 47 5 564 9 Lopez O L et al Accuracy of four clinical diagnostic criteria for the diagnosis of neurodegenerative dementias Neurology 1999 53 6 1292 9 Nagy Z et al Accuracy of clinical operational diagnostic criteria for Alzheimer s disease in relation to different pathological diagnostic protocols Dement Geriatr Cogn Disord 1998 9 4 219 6 Hogervorst E et al The validity and reliability of 6 sets of clinical criteria to c
146. NN 1 3 7 11 44 40 93 14 56 43 25 9396 449 81 9975 24 6575 M N 4 r ET DV NN 1 93 80 81 9975 5996 9394 NN 88 92 75 96 74 99 n CI H N PET RS 0 44 0 91 x PRIX 0 72 gc c SoT 6 PET SoT 7 31 6 SoT N 68 PAS SoT BSS iS OIN rail yer Ai 95 CI 95 CI 95 CI 95 CI IER 17 8 25 BSS CI 5196 6896 7396 45 36 67 47 85 53 88 29 62 x 7 PET SoT N 68 PAS
147. gt VH c 1 lt gt 1 D in vitro 1 6 B ABi ao invitro Ka HX67nM C350 BEXIDABU X Fo PrcG mA 2 4 Dimethylaminophenyl 6 iodobenzothiazole TZDM Ka 3 4 nM B CABia TZDM I 50 ECs 118 nM TZDM ECso 14 nM 15 Q invitro 1 7 AD AD
148. 2 ER C Bi m mu zn GE067 021 PET GE067 021 PET vj 5 1 9 ZEE fr P NAA dd E 55b mus H amp E EL Hi BUT
149. 3 OL CAD ih OO B Eam 4M E 1 Hio 13 23 M f H 14 19 E 9 1 1 1
150. R AUN ES 2B AD 8 A HIE AD AU AD AD 1 PET AD PET PET HH 2 FPR 0 41 AB
151. gt 2 3 2 H o 0 1 C gnu H QA ET RH 1 duo d TY SO B 40 100 gn RH NE 3 1 2 6
152. lassify Alzheimer s disease and vascular dementia in cases confirmed post mortem added value of a decision tree approach Dement Geriatr Cogn Disord 2003 16 3 170 80 4 Kukull W A et al The validity of 3 clinical diagnostic criteria for Alzheimer s disease Neurology 1990 40 9 1364 9 Bo M et al White coat effect among older patients with suspected cognitive impairment prevalence and clinical implications nt J Geriatr Psychiatry 2009 2A 5 509 17 Eder A F et al Donor survey to assess facial flushing during automated red cell collections and medication use J Clin Apher 2011 26 3 116 22 Stephens M Chapter 1 Introduction in Stephens Detection of New Adverse Drug Reactions 5th ed eds Talbot J and Waller P John Wiley amp Sons Ltd 2004 p 63 9 PET PET 2015 2 18 H HUE http www jsnm org system files PET pdf accessed March 31 2015 50
153. ma Activity Concentration mL re m 0 00 1 00 2 00 300 4 00 5 00 Time h d 3 ALZ103 GE067 014 F 1 AB 1 24 3 lt gt 1 1
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