成果報告書詳細
管理番号20140000000562
タイトル*平成23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2014/8/5
報告書年度2011 - 2011
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
英文要約TITLE:Research project for the development of a systematic method for the assessment of Alzheimer's disease (FY2007-FY2012). FY2011 Annual Report
(1) CLINICAL CORE promoted recruitment of study participants, and completed screening of 712 by Mar. 2012, of which 541 (normal aged: 152, MCI: 244, eAD: 145) from 38 clinical sites met the inclusion criteria. CSF was obtained from 40%, FDG-PET was performed in 67%, and amyloid PET was done in 42%, of the total subjects. Recruitment of new subjects has been finished in the end of this fiscal year. (2)MRI CORE performed the correction of MRI data by automatically 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 PET score. Effects of factors like age, education were examined. Data comparison between FDG and PiB was also done. Sample size of clinical studies for new drugs by using FDG-PET was simulated. b) A total of 1577 PET scans were performed by Mar. 2012, and the data were sent for QC check. Effects of radioactivity from outside of the field of view were also evaluated. All those QC data are stored in the database for data analysis. c)In amyloid PET activity, Compatibility in data of US-ADNI, AIBL and J-ADNI was confirmed and Effects of APOE4, aging and ethical difference were evaluated. (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 2504 blood samples and 312 CSF samples (BL:192, 12mo:120) 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, amyloid-PET and data of US-ADNI. International QC program for CSF biomarker standardization is also on-going. (6)NEW BIOMARKERS(BM):a) IBL improved the ELISA systems for p3-Alca. b) Eidia 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. reported on “Altered g-secretase activity in mild cognitive impairment and Alzheimer’s disease” (EMBO Mol MED 4:344-352, 2012), which was found through examining bCTF processing pathway. e) Niigata U. found several genes related with AD progression (NFT and plaque) 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-Alca, a fragment of alcadein, as a candidate for plasma BM of AD.
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