成果報告書詳細
管理番号20110000001497
タイトル*平成22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2011/11/23
報告書年度2010 - 2010
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」
英文要約TITLE:Research project for the development of a systematic method for the assessment of Alzheimer's disease (FY2007-FY2011). FY2010 Annual Report
(1)CLINICAL CORE promoted recruitment of study participants, and completed screening of 626 by Mar. 2011, of which 482 (normal aged:152, MCI:229, eAD:101) from 38 clinical sites met the inclusion criteria. CSF was obtained from 38%, FDG-PET was performed in 66%, and amyloid PET was done in 40%, of the total subjects. The MMSE-J proved to be a sensitive screening test in detecting dementia.(2)MRI CORE performed the correction of MRI data by reducing signal inhomogeneity/geometric distortion with IT core. The corrected data have been analyzed by Free Surfer program. The volumetry of manually traced data of HIP and ER cortex was also done.(3)PET CORE:a) Group comparison of FDG-PET was performed and quantitative evaluation was also done by AD t-sum value. Effects of factors like age, education were examined. Data comparison between FDG and PiB was also done. b)Site certification has been completed in all the 24 FDG-PET and 13 amyloid-PET centers. A total of 925 PET scans were performed by Jan. 2011, and the data were sent for QC check. All those QC data are stored in the database for data analysis. c)In amyloid PET activity, evaluation protocol for BF227 was also established. A total of 269 scans were performed. Compatible data with those of US-ADNI, AIBL were obtained.(4)IT CORE: In Data Center IT core has continued to store the clinical data, MRI/PET images in the database system. QC/assurance system is also working. With MRI core, correction and analysis of MRI data are also performed.(5)BIOMARKER CORE:A total of 1715 blood samples and 239 CSF samples (BL:160, 12mo:79) are collected. APOE genotyping is regularly conducted and conc.of Aβ42, total-tau, P-tau in the CSF were determined by xMAP system. The data were examined with comparing to clinical entity, age and amyloid-PET. (6)NEW BIOMARKERS(BM): a)IBL developed the ELISA systems for detecting various Aβ-fragments. An ELISA kit for Aβ43 was marketed this year. ELISA system for p3-Alcα was also established. b)Sanko Junyaku has conducted a longitudinal study for AD/MCI/age-matched control by measuring truncated form of plasma Aβ(x-42). c)PSS has searched BM candidates applied to PSS’s ProScope/M1200. d)Doshisha U. measured BM candidates like Aβ fragments by MS. Production pathway was also examined. In collaboration with IBL, low Aβ43 in CSF was established as well as Aβ42 as a BM of AD/MCI. The ratios of Aβ40/Aβ43 and Aβ38/Aβ42 in CSF, if they are large enough, were found to be excellent markers to distinguish between controls and AD/MCI. e)Niigata U. found several genes related with AD progression by using exon array analysis in collaboration with Brain Bank. f)Hirosaki U. has evaluated the significance of Aβ oligomer for AD BM candidate. g)Hokkaido U has investigated the possibility of p3-Alcα, a fragment of alcadein, as a candidate for plasma BM of AD.
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