{"id":"hum0235","version":1,"url":"https://humandbs.dbcls.jp/research/hum0235/v1","datePublished":"2021-04-06","versions":[{"version":1,"datePublished":"2021-04-06"}],"title":{"ja":"プレクリニカル期におけるアルツハイマー病に対する客観的画像診断・評価法の確立を目指す臨床研究","en":"Evaluation and imaging study of the preclinical stage of Alzheimer's disease in Japan"},"summary":{"aims":{"ja":"プレクリニカルアルツハイマー病（AD）患者において、心理検査、MRIやPET画像、血液髄液などを採取し、プレクリニカル期ADにおける客観的画像診断および評価法の確立を目指す","en":"A study aiming to establish objective imaging and evaluation methods in preclinical Alzheimer's disease by collecting biochemical data such as psychological tests, MRI and PET images, and blood cerebrospinal fluid over time in patients with preclinical AD"},"methods":{"ja":"健常高齢者にアミロイドPETを施行し、アミロイド蓄積が認められるプレクリニカルAD群を抽出する。蓄積の認められない被験者は健常対象者として登録。その他に心理検査でMCIと診断された被験者を登録した。それらの対象者に、詳細な心理検査、MRI、FDG-PET、血液、髄液検査を施行し、6ヶ月から36ヶ月経過観察した。","en":"We performed amyloid PET in healthy elderly and enrolled subjects with amyloid accumulation in the preclinical AD group. Subjects without amyloid accumulation were enrolled as healthy subjects. In addition, subjects who were diagnosed with MCI by psychological examination were enrolled. Those subjects underwent detailed psychological examination, MRI, FDG-PET, blood, and cerebrospinal fluid examination, and were followed up for 6 to 36 months."},"targets":{"ja":"アミロイド蓄積が認められなかった健常高齢者：25名\nプレクリニカルAD（ICD10：F00）：3症例\n早期MCI（軽度認知症）（ICD10：F06.7）：7症例\n後期MCI（ICD10：F06.7）：5症例","en":"25 healthy elderly people without cognitive impairment\npreclinical AD (ICD10: F00): 3 cases\nearly MCI (ICD10: F06.7): 7 cases\nlate MCI (ICD10: F06.7): 5 cases"},"url":{"ja":[{"url":"https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022596","text":"https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022596"}],"en":[{"url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022596","text":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022596"}]}},"listingSummary":{"methods":{"ja":"脳画像ベースの病態解明","en":"Brain imaging-based pathology analysis"},"targets":{"ja":"健常高齢者群：25名\nプレクリニカルAD：3名\n早期MCI：7名\n後期MCI：5名\n（日本人）","en":"25 healthly controls\n3 preclinical AD\n7 early MCI\n5 late MCI\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、アミロイド蓄積が認められなかった健常高齢者25名、プレクリニカルAD3名、早期MCI（軽度認知症）7症例、後期MCI5症例のデータを公開した。追跡期間は、半年～3年間。","en":"Data obtained from participants enrolled in a longitudinal study (healthly elderly controls: 25, preclinical AD: 3, early MCI: 7, late MCI: 5) was released. The follow-up span of the study was 6 to 36 months."},"dataProviders":[{"name":{"ja":"嶋田 裕之","en":"Hiroyuki Shimada"},"organization":{"name":{"ja":"大阪市立大学大学院医学研究科 放射線診断学・IVR学","en":"Department of Diagnostic and Interventional Radiology, Osaka City University Graduate School of Medicine"}}}],"researchProjects":[{"name":{"ja":"AMED Preclinical AD study group (研究参加施設一覧、引用する際の記載要領 [UMIN登録情報の「その他関連情報/Other related information」の欄参照])","en":"AMED Preclinical AD study group (Clinical Sites, Citation Information [see 'Other related information'])"},"url":{"ja":[{"url":"https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022596","text":"https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022596"}],"en":[{"url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022596","text":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022596"}]}}],"grants":[{"title":{"ja":"プレクリニカル期におけるアルツハイマー病に対する客観的画像診断・評価法の確立を目指す臨床研究","en":"Evaluation and imaging study of the preclinical stage of Alzheimer's disease in Japan"},"agency":{"ja":"日本医療研究開発機構（AMED） 認知症研究開発事業","en":"Research and Development Grants for Dementia, Japan Agency for Medical Research and Development (AMED)"},"grantIds":["JP19dk0207020"]}],"relatedPublications":[{"title":"A Japanese Multicenter Study on PET and Other Biomarkers for Subjects with Potential Preclinical and Prodromal Alzheimer's Disease","doi":"https://doi.org/10.14283/jpad.2021.37","datasets":["JGAD000378"]}],"datasets":["JGAD000378"],"controlledAccessUsers":[{"principalInvestigator":{"ja":"井狩 彌彦","en":"Yasuhiko IKARI"},"affiliation":{"ja":"臨床研究推進センター, 神戸医療センター中央市民病院","en":"Molecular Imaging  Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital"},"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":"Development of imaging biomarkers on clinical study image database for Alzheimers disease."},"periodStart":"2021-06-16","periodEnd":"2024-05-01","datasets":["JGAD000378"]}]}