成果報告書詳細
管理番号20100000001577
タイトル*平成21年度中間年報 基礎研究から臨床研究への橋渡し促進技術開発/橋渡し促進技術開発 アルツハイマー病総合診断体系実用化プロジェクト/根本治療の実現に向けて
公開日2011/4/20
報告書年度2009 - 2009
委託先名バイオテクノロジー開発技術研究組合
プロジェクト番号P07022
部署名バイオテクノロジー・医療技術開発部
和文要約和文要約等以下本編抜粋:1. 研究開発の内容及び成果等
本プロジェクトは、画像診断を中心としたAD(アルツハイマー病)発症の客観指標の標準化を行うことにより、AD 根本治療薬の早期創出と治験の加速化を達成するとともに、文科省「先端脳プロジェクト」で得られた成果を利用して、体液バイオマーカー(生化学マーカー)の検証、実用化を加速し、画像・生化学診断を融合したAD 総合診断体系の実用化を目指しており、以下の研究開発項目から構成されている。
研究開発項目1「AD 臨床評価の標準化研究 (J-ADNI 臨床研究)」
研究開発項目2「J-ADNI によるDB 構築と解析ソフトウェア開発研究」
研究開発項目3「AD、MCI 診断マーカーに関する技術開発」
研究開発項目4「総合調査研究」
平成21年度での各研究開項目の成果は、以下の通りである。
研究開発項目1「AD 臨床評価の標準化研究(J-ADNI 臨床研究)」
研究分担先:GE ヘルスケア・ジャパン(株)、(株)島津製作所、東芝メディカルシステムズ(株)、(株)日立メディコ、シーメンス旭メディテック(株)、(株)マイクロン、日本メジフィジックス(株)、製薬企業11社
共同実施先:東京大学・岩坪研、東北大学・荒井研、筑波大学・朝田研、埼玉医科大学・松田研、国立長寿医療センター・伊藤健吾研、(財)先端医療振興財団・千田研、東京都健康長寿医療センター研究所・石井研、近畿大学・石井研、全国38臨床研究施設
本研究開発項目は、以下のコアがそれぞれ、分担・連携して研究を推進した。
(1)臨床コア
(2)MRI コア
(3)PET コア
英文要約TITLE: Research project for the development of a systematic method for the assessment of Alzheimer's disease. (1)CLINICAL CORE promoted recruitment of study participants, and completed screening of 394 individuals, of which 288 (normal aged:117, MCI:111, early AD:60) from 35 clinical sites met the inclusion criteria. Baseline data from clinico-psychological work up were compatible to those of US-ADNI, ensuring the equivalence of the test batteries. CSF was obtained from 39%, FDG-PET was performed in 74%, and amyloid PET was done in 45%, of the total participants. (2) MRI CORE developed a new automatic preprocessing method of MRI data for highly precise volumetry by reduction of signal inhomogeneity/geometric distortion with the aid of IT core. Uploaded MRI data are checked using on-line software by 9 neuroradiologists. Ischemic scoring was also performed, using Fazekas score. (3)PET CORE: a) A central image interpretation system has been employed in FDG-PET activity. Statistical image analysis and ROI analysis with preliminary data have also advanced. For development of a central interpretation system of PET images, a data accumulation/management system was constructed. b) Site certification has been finished in 23 of the 24 FDG-PET centers and in 11 of the 13 amyloid-PET centers. A total of 520 PET scans were performed by March 2010, and the data were sent for QC check. All those QC data are stored in the database for future analysis. c) In amyloid PET activity, since differences among institutes were more strictly adjusted, the possibility of J-ADNI’s providing information at more excellent sensitivity than US-ADNI was demonstrated. Analysis on some of baseline data clarified the influence of APOE4 on amyloid accumulation. (4)IT CORE: A VPN between the participating sites and the Data Center and a database system which manages the clinical data, MRI/PET images, and biomarker/genotyping results were established. QC/assurance system for these data was also set up. With MRI core, MRI data correcting methods including a brain extraction program were also developed. (5)BIOMARKER CORE: The assignment is the storage of the bioresources, measurement of biomarkers, and preparation of DNA followed by APOE genotyping. Biochemical tests of 342 samples and APOE genotyping of 328 subjects were completed. Conc. of Aβ, total-tau, and P-tau in the CSF were preliminarily determined by using xMAP system. (6)NEW BIOMARKERS: a) IBL developed the detection system of various Aβ-fragments by using anti-Aβ-epitope-library. ELISA kits for N3PE-40 and Aβ1-38 were marketed this year. b) Sanko Junyaku has been conducting cross-sectional study for AD and age-matched control by measuring truncated form of plasma Aβ(x-42). c) PSS developed the pretreatment methods of concentrating biomarkers for MS measurement. The protocols were established on PSS’s two automation systems. d) Yamatake: The developed proto type of DNA chip was tested by using the AD risk candidate genes.
ダウンロード成果報告書データベース(ユーザ登録必須)から、ダウンロードしてください。

▲トップに戻る