{"id":"hum0043","version":1,"url":"https://humandbs.dbcls.jp/research/hum0043/v1","datePublished":"2016-01-29","versions":[{"version":1,"datePublished":"2016-01-29"}],"title":{"ja":"アルツハイマー病総合診断体系実用化プロジェクト（J-ADNI全国臨床研究）","en":"Japanese Alzheimer's disease neuroimaging initiative (J-ADNI)"},"summary":{"aims":{"ja":"アルツハイマー病（AD）治療薬の薬効評価基準の最適化を行うために、ADの病態を忠実に反映するサロゲートマーカー (surrogate marker)を定めておく必要がある。J-ADNI研究は、MRIやPETなどの画像サロゲートマーカーの長期的変化に関する一定の基準値を作成するとともにその妥当性を証明するために臨床/神経心理検査データ、血液・脳脊髄液サンプルを並行して収集することを目的とする。","en":"Japanese ADNI aims to establish imaging and biofluid markers that can predict and monitor the progression of changes in the brains of elderly individuals with AD, mild cognitive impairment (MCI) or normal cognition, and eventually be used as a surrogate markers for the clinical trials of DMDs for AD."},"methods":{"ja":"次の神経心理学的検査 (MMSE, WMS-R Logical Memory I and II, Digit Span, Category Fluency, Trails A and B, Digit symbol, Boston Naming Test, Geriatric Depression Scale, Clock drawing, Neuro-psychiatric Inventory Q, ADAS-CogJ, CDR Scale､ 積木模様、知識、Functional activity questionnaire)を行う。\n1.5テスラMRIによる脳の形態画像撮像： ADNI統一パルスシーケンスに従い、頭部の矢状断の3D MPRAGE撮影を行う。\nFluorodeoxy glucose-PET による脳糖代謝画像撮像、11C-PIBもしくは11C-BF227プローブを用いたアミロイドPETを施行する。\n体液生化学検査：脳脊髄液採取については、承諾の得られたMCI, ADならびに健常高齢者群の被験者より腰椎穿刺により1, 12ヶ月時に脳脊髄液を採取しAβ, tauをはじめとするAD関連タンパク質を定量する。血液採取(20ml)は全例全時点で行う。\n遺伝子解析： リスク遺伝子であるApoE遺伝子型と表現型（症状）を比較する。","en":"The research protocol includes structural MRI analysis, FDG and amyloid PET, CSF sampling, apoE genotyping, combined with a set of clinical and psychometric tests that were prepared to achieve the highest compatibility to those used in US-ADNI."},"targets":{"ja":"研究参加者(縦断研究組入数)537名（内訳：健常高齢者健常群154名、軽度認知機能障害（MCI）234名、早期アルツハイマー病149名）","en":"Participants enrolled in a longitudinal study: 537 (healthly elderly controls: 154, mild cognitive impairment (MCI): 234, Alzheimer's disease (AD): 149)"},"url":{"ja":null,"en":null}},"listingSummary":{"methods":{"ja":"脳画像ベースの病態解明","en":"Neuroimaging-based pathophysiology elucidation"},"targets":{"ja":"MCI：234名\nAD：149名\n健常高齢者群：154名\n（日本人）","en":"234 MCI\n154 AD\n149 healthly controls\n(Japanese)"},"typeOfData":{"ja":"脳画像\n臨床情報","en":"Neuroimage\nClinical Info"}},"releaseNote":{"ja":"このバージョンでは、縦断研究に組入れられた研究参加者全員537名（内訳：健常高齢者健常群154名、軽度認知機能障害（MCI）234名、早期アルツハイマー病(AD)149名）のデータを公開した。追跡期間は、早期アルツハイマー病：2年間、健常高齢者健常群ならびに軽度認知機能障害（MCI）：3年間。","en":"Data obtained from all 537 participants enrolled in a longitudinal study (healthly elderly controls: 154, mild cognitive impairment (MCI): 234, Alzheimer's disease (AD): 149) was released. The follow-up span of the study was 2 years for AD and 3 years for the controls and MCI."},"dataProviders":[{"name":{"ja":"岩坪 威","en":"Takeshi Iwatsubo"},"organization":{"name":{"ja":"東京大学大学院医学系研究科 神経病理学分野","en":"Department of Neuropathology, Graduate School of Medicine, the University of Tokyo"}}}],"researchProjects":[{"name":{"ja":"Japanese Alzheimer's Disease Neuroimaging Intiative (J-ADNI) (著者一覧、引用する際の記載要領)","en":"Japanese Alzheimer's disease neuroimaging initiative (J-ADNI) (List of Authors, Citation Information)"},"url":{"ja":null,"en":null}}],"grants":[{"title":{"ja":"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","en":"Research Project for the Development of a Systematic Method for the Assessment of Alzheimer's Disease"},"agency":{"ja":"国立研究開発法人新エネルギー・産業技術総合開発機構(NEDO) 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","en":"New Energy and Industrial Technology Development Organization of Japan (NEDO) Translational Research Promotion Project"},"grantIds":["20100000001577"]},{"title":{"ja":"アルツハイマー病発症と進展の客観的評価法確立のための多施設縦断臨床研究:J-ADNI コアスタディ","en":"Multisite longitudinal study for the evaluation of clinical manifestation and progression of Alzheimer disease: J-ADNI core study"},"agency":{"ja":"厚生労働科学研究費補助金認知症対策総合研究事業","en":"Health Labour Sciences Research Grant Research on Dementia"},"grantIds":["H19-認知症-指定-024"]},{"title":{"ja":"J-ADNIコアスタディ：画像・バイオマーカーの解析・活用と臨床研究体制の確立","en":"J-ADNI core study: analysis and application of imaging biomarkers and establishment of clinical study network"},"agency":{"ja":"厚生労働科学研究費補助金認知症対策総合研究事業","en":"Health Labour Sciences Research Grant Research on Dementia"},"grantIds":["H22-認知症-指定-009"]},{"title":{"ja":"ヒト脳疾患画像データベース統合化研究","en":"Study on integration of the human brain related diseases imaging data"},"agency":{"ja":"国立研究開発法人科学技術振興機構ライフサイエンスデータベース統合推進事業（統合化推進プログラム）","en":"Life Science Database Integration Project (Database Integration Coordination Program) of Japan Science and Technology Agency"},"grantIds":null}],"relatedPublications":[{"title":"Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials.","doi":"https://doi.org/10.1016/j.jalz.2018.03.009","datasets":["JGAD000051"]}],"datasets":["JGAD000051"],"controlledAccessUsers":[{"principalInvestigator":{"en":"Michael Donohue"},"affiliation":{"en":"Alzheimers Therapeutic Research Institute, University of Southern California"},"country":{"ja":"アメリカ合衆国 (カリフォルニア州)","en":"California, United States"},"researchTitle":{"ja":"Long-term disease trajectories and clinical trial design and analysis","en":"Long-term disease trajectories and clinical trial design and analysis"},"periodStart":"2016-03-30","periodEnd":"2021-03-26","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"高橋 竜一","en":"Ryuichi Takahashi"},"affiliation":{"ja":"神経内科, 兵庫県立リハビリテーション西播磨病院","en":"Department of Neurology, Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"MCIの局所脳萎縮に対するアミロイド沈着及びAPOE4の効果（J-ADNI研究）","en":"Search for ApoE4 effects on amyloid deposition and gray matter atrophy by using of PiB-positive MCI"},"periodStart":"2016-04-27","periodEnd":"2018-09-06","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"石井 賢二","en":"Kenji Ishii"},"affiliation":{"ja":"研究所神経画像研究チーム, 地方独立行政法人東京都健康長寿医療センター","en":"Neuroimaging Research Team, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"NBDCヒトデータベースを利用したJ-ADNI研究PETデータの解析","en":"Analysis of J-ADNI PET data using NBDC human database."},"periodStart":"2016-05-02","periodEnd":"2021-03-19","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"松田 博史","en":"Hiroshi Matsuda"},"affiliation":{"ja":"脳病態統合イメージングセンター, 国立精神・神経医療研究センター","en":"Integrative Brain Imaging Center, National Center of Neurology and Psychiatry"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"Japanese Alzheimer's disease neuroimaging initiative 公開データを用いた画像研究","en":"Study on neuroimaging using open files from Japanese Alzheimer's disease neuroimaging initiative"},"periodStart":"2016-06-01","periodEnd":"2021-03-01","datasets":["JGAD000051"]},{"principalInvestigator":{"en":"Weining Robieson"},"affiliation":{"en":"Data and Statistical Sciences, AbbVie"},"country":{"ja":"アメリカ合衆国 (イリノイ州)","en":"Illinois, United States"},"researchTitle":{"ja":"Evaluation of longitudinal changes in clinical assessments and biomarkers for subjects with mild cognitive impairment (MCI), Alzheimer's Disease (AD) and normalcontrols using Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) data","en":"Evaluation of longitudinal changes in clinical assessments and biomarkers for subjects with mild cognitive impairment (MCI), Alzheimer's Disease (AD) and normalcontrols using Japanese Alzheimer's Disease Neuroimaging Initiative 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健","en":"Ken Aoshima"},"affiliation":{"ja":"hhcデータクリエーションセンター, エーザイ株式会社","en":"hhc Data Creation Center, Eisai Co., Ltd."},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"J-ADNIデータを用いたAD疾患修飾薬に関連した解析及びADに関するバイオマーカーの探索的研究","en":"Comprehensive AD biomaker and disease modifying drug development related analysis by using J-ADNI data"},"periodStart":"2016-09-23","periodEnd":"2027-03-31","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"菊池 正史","en":"Masashi Kikuchi"},"affiliation":{"ja":"グローバル研究開発本部　クリニカルリサーチ　中枢神経領域, MSD株式会社","en":"Development Clinical Research Neuroscience Group, MSD K.K. Japan"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"日本人の軽度認知症患者及びアルツハイマー病患者における疾患の進行に関する研究","en":"Study to investigate disease progression in Japanese mild cognitive impairment and Alzheimer's disease patients"},"periodStart":"2016-10-12","periodEnd":"2021-03-18","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"鈴木 洋史","en":"Hiroshi Suzuki"},"affiliation":{"ja":"薬剤部, 東京大学医学部附属病院","en":"Department of Pharmacy, The University of Tokyo Hospital"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"J-ADNIデータを用いた日本人におけるアルツハイマー病進行過程の解析","en":"An Analysis of The Progression of Alzheimer's Disease in The Japanese Population by Using J-ADNI Data"},"periodStart":"2017-01-11","periodEnd":"2025-09-02","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"大河内 正康","en":"Masayasu Okochi"},"affiliation":{"ja":"精神医学教室, 大阪大学大学院医学系研究科","en":"Department of Psychiatry, Osaka University Graduate School of Medicine"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"アルツハイマー病超早期診断バイオマーカーの開発のために、J-ADNI研究で得られたデータを利用する","en":"Utilization of Data obtained by J-ADNI research for the purpose of development of blood-based Alzheimer's disease biomarker"},"periodStart":"2017-02-02","periodEnd":"2021-12-20","datasets":["JGAD000051"]},{"principalInvestigator":{"en":"Joyce Suhy"},"affiliation":{"en":"Bioclinica, Inc."},"country":{"ja":"アメリカ合衆国 (カリフォルニア州)","en":"California, United States"},"researchTitle":{"ja":"vMRI validation on Toshiba Scanners using J-ADNI data","en":"vMRI validation on Toshiba Scanners using J-ADNI data"},"periodStart":"2017-04-04","periodEnd":"2019-02-07","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"鈴木 利治","en":"Toshiharu Suzuki"},"affiliation":{"ja":"大学院薬学研究院, 北海道大学","en":"Faculty of Pharmaceutical Sciences, Hokkaido University"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"アルツハイマー病血液バイオマーカーp3-Alc解析におけるNBDCヒトデータベースの利用","en":"NBDC Human Database use for analysis of p3-Alc peptides, the blood biomarker for Alzheimer's disease"},"periodStart":"2017-05-02","periodEnd":"2024-11-15","datasets":["JGAD000051"]},{"principalInvestigator":{"en":"Danielle Harvey"},"affiliation":{"en":"Division of Biostatistics, UC Davis"},"country":{"ja":"アメリカ合衆国 (カリフォルニア州)","en":"California, United States"},"researchTitle":{"ja":"Comparison of Japan-ADNI and North America ADNI","en":"Comparison of Japan-ADNI and North America ADNI"},"periodStart":"2017-05-02","periodEnd":"2021-03-26","datasets":["JGAD000051"]},{"principalInvestigator":{"en":"Jae-Won Jang"},"affiliation":{"en":"Department of Neurology, Kangwon National University Hospital"},"country":{"ja":"韓国","en":"South Korea"},"researchTitle":{"ja":"COMPREHESIVE VISURAL RATING SCALE ON MRI: APPLICATION TO ALZHEIMER’S DISEASE, MILD COGNITIVE IMPAIRMENT AND SUBJECTIVE MEMORY IMPAIRMENT","en":"COMPREHESIVE VISURAL RATING SCALE ON MRI: APPLICATION TO ALZHEIMER’S DISEASE, MILD COGNITIVE IMPAIRMENT AND SUBJECTIVE MEMORY IMPAIRMENT"},"periodStart":"2017-05-02","periodEnd":"2021-01-23","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"佐々木 雅之","en":"Masayuki Sasaki"},"affiliation":{"ja":"大学院医学研究院保健学部門医用量子線科学分野, 九州大学","en":"Department of Health Sciences, Graduate School of Medical Sciences, Kyushu University"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"認知症臨床研究データベースを利用した認知症に対する画像バイオマーカーの確立に関する研究","en":"Study of imaging biomarkers for dementia based on the clinical research database"},"periodStart":"2017-06-21","periodEnd":"2022-03-03","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"椎野 顯彦","en":"Akihiko Shiino"},"affiliation":{"ja":"神経難病研究センター, 滋賀医科大学","en":"Molecular Neuroscience Research Center, Shiga University of Medical Science"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"J-ADNIのデータベースを用いた認知症の画像診断","en":"Neuroimage diagnosis of dementia using J-ADNI 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diagnosis"},"periodStart":"2017-09-05","periodEnd":"2024-09-06","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"岩田 淳","en":"Atsushi Iwata"},"affiliation":{"ja":"神経内科, 東京大学医学部附属病院","en":"Department of Neurology, The University of Tokyo Hospital"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"J-ADNI研究において取得された末梢血由来ゲノムを利用した網羅的エピゲノム解析","en":"Comprehensice epigenome analysis of J-ADNI peripheal blood samples"},"periodStart":"2017-09-14","periodEnd":"2021-08-19","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"山元 敏正","en":"Tosimasa Yamamoto"},"affiliation":{"ja":"神経内科 　脳卒中内科, 埼玉医科大学病院","en":"Neurology, Saitama Medical University"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"脳画像解析ソフトウェアを用いた脳画像変化を客観的評価する手法のパーキンソン症候群、アルツハイマー型認知症を含む変性疾患に対する検討","en":"Evaluation of a method for objectively evaluating brain image change using brain image analysis software in degenerative diseases including Parkinson's syndrome and Alzheimer type 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diagnostic marker in Alzheimer's disease (AD) patients, mild cognitive impairment (MCI) patients, and healthy control (HC) people using Alzheimer's disease clinical databases that are collected and opened by domestic and international organizations"},"periodStart":"2017-12-11","periodEnd":"2021-01-25","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"深見 忠典","en":"Tadanori Fukami"},"affiliation":{"ja":"大学院理工学研究科, 山形大学","en":"Graduate school of science and engineering, Yamagata University"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"J-ADNIデータベースを用いたMRI/PET画像統合による縦断的解析","en":"Longitudinal analysis for J-ADNI database by MRI/PET image fusion"},"periodStart":"2017-12-26","periodEnd":"2021-01-22","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"山口 修平","en":"Shuhei Yamaguchi"},"affiliation":{"ja":"医学部内科学第三, 島根大学","en":"Department of Internal Medicine III, Shimane University"},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"機械学習を活用した脳のMRI画像診断支援プログラム開発","en":"Development of diagnosis support program using machine learning for brain MRI"},"periodStart":"2018-01-09","periodEnd":"2035-03-31","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"石田 学","en":"Manabu ISHIDA"},"affiliation":{"ja":"株式会社ERISA","en":"ERISA Co., Ltd."},"country":{"ja":"日本","en":"Japan"},"researchTitle":{"ja":"機械学習を活用した脳のMRI画像診断支援プログラム開発","en":"Development of diagnosis support program using machine learning for brain MRI"},"periodStart":"2018-01-09","periodEnd":"2025-03-31","datasets":["JGAD000051"]},{"principalInvestigator":{"ja":"小野 徹太郎","en":"Tetsutaro Ono"},"affiliation":{"ja":"情報イノベーション事業部Ｃ＆Ｉセンター第１マーケティングコミュニケーション本部第１企画開発部ＩＣＴビジネス開発グループ, 大日本印刷","en":"Communication & Information Center / Information Innovation Operations, Dai Nippon Printing Co., 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