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J-ADNI: Observational Early AD Study in Japan - Summary & Current Status

Learn about J-ADNI, the 1st nationwide observational study for early Alzheimer's disease in Japan since 2007, with 38 clinical sites and 600 subjects. Explore data released for research and collaborative analyses to support disease-modifying therapies. Get insights into cognitive function, conversion rates, biomarkers, and ongoing initiatives towards successful clinical trials. Join the mission of J-DCS in establishing a Trial Ready Cohort to advance Alzheimer's research.

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J-ADNI: Observational Early AD Study in Japan - Summary & Current Status

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  1. Japanese ADNIsummary of J-ADNI1 data and current status on July 2016 Takeshi Iwatsubo, PI of J-ADNI Atsushi Iwata, Clinical core PI of J-ADNI2/AMED preclinical

  2. Japanese ADNI The 1st nationwide observational early AD study in Japan Sapporo • 7-year study (since 2007) • 38 clinical sites • Goal: 600 subjects • 537 finally enrolled by Apr 2013 Hirosaki Akita Iwate • 1.5T MRI • (3D MPRAGE, ADNI phantom) • PET • ---FDG 67% (IC obtained) • ---amyloid 42% (IC obtained) (PIB 15 sites, BF227 2 sites) • Blood + apoE (100%), immortalized lymphoblasts • CSF 40% (IC obtained) • Clinical (14 test batteries) Tohoku Niigata Gumma, Tsukuba, Mihara Kanazawa ShinshuNCNPSaitama Kyorin Tokyo Met Geriatric Hosp Tokyo Med col, Nippon Med, Juntendo,TMDU, Tokyo Asahi/Chiba-higashi Kyoto Kyoto Pref Tottori Natl Longev., Hamamatsu, Kurihama,Yokohama Kobe, Osaka City Osaka, Nara Okayama Kagawa Fukuoka Kumamoto

  3. J-ADNI database • Released for research use from the National Bioscience Database Center (NBDC) of JST, Japan, on Jan 29, 2016. • Please obtain approval from local ethics committee and apply to NBDC at http://humandbs.biosciencedbc.jp/en/data-use • Total number of datasets • 3691 Case Report Forms • 3078 Cognitive Test Worksheets • 2550 Clinical Dementia Rating • 2459 1.5T MRI images, 256 3T MRI images • 1387 FDG PET images • 594 amyloid PET images • 3067 blood tests • 339 CSF Ab and tau Collaborative analysis of J-ADNI/NA-ADNI initiated by Iwatsubo, Iwata, Beckett and Donohue

  4. J-ADNI Demographics Red: US-ADNI (WW-ADNI@Sendai, 2009)

  5. Entry survival 100 50 0 0 6 12 18 24 36 Completion NC 89.6% (3y), MCI 74.8% (3y), AD 81.2% (2y)

  6. J-ADNI Cognitive Function baseline

  7. MMSE individual performances in J-ADNI NC MCI AD 30 30 30 20 20 20 10 10 10 0 0 0 0 6 12 18 24 36 0 6 12 24 0 6 12 24 36 MMSE decline rate NC -0.039/yr, MCI -1.29/yr, AD -1.38/yr

  8. CDR sum of boxes individual performance in J-ADNI 20 20 20 15 15 15 10 10 10 5 5 5 0 0 0 0 6 12 24 36 0 6 12 18 24 36 0 6 12 24 NC 0.04/yr, MCI 1.08/yr, AD 1.28/yr

  9. ADAS-cog11 trend in J-ADNI NC MCI AD 50 50 50 40 40 40 30 30 30 20 20 20 10 10 10 0 0 0 0 6 12 18 24 36 0 6 12 24 0 6 12 24 36 NC: -0.09/yr, MCI +1.93/yr, AD: +2.11/yr

  10. Conversion rate NC to MCI 100 1 year conversion rate 1.3% 2 year conversion rate 2.6% 3 year conversion rate 4.5% 50 0 0 6 12 18 24 36 MCI to AD 100 1 year conversion 26.2% (16.1% in US-ADNI1) 2 year conversion 41.5% 3 year conversion 52.1% 50 0 0 6 12 18 24 36

  11. MCI to AD conversion by PET amyloid positivity 100 80 17.9% 60 40 55.6% 20 0 0 6 12 18 24 36 Conversion rate negative 6.0%/yr, positive 18.5%/yr

  12. MCI MMSE by Ab pathology MCI without Aβ biomarker 30 20 MCI with pos Aβ biomarker 10 0 0 12 24 36 MCI with pos Aβ biomarker -1.43/yr MCI with neg Aβ biomarker -0.14/yr

  13. MCI CDR SOB by Ab pathology 10 8 MCI with pos Aβ biomarker 6 4 MCI without Aβ biomarker 2 0 0 12 24 36 MCI with pos Aβ biomarker 1.13/yrr MCI without Aβ biomarker 0.29/yr

  14. PiB-PET in J-ADNI Kenji Ishii, amyloid PET core of J-ADNI ε4- ε4+ 8%55% ε4- ε4+ 41% 100% ε4- ε4+ 84% 100% Co-plot of mcSUVR of PiB and CSF Ab(1-42) mcSUVR and PiB(+)vity by Group and ApoE4 24% 66% 93% by Visual Reads 24% 65% 90% by mcSUVR cut off アミロイドＰＥＴ陽性は脳脊髄液 Aβ(1-42)低値とよく一致 （髄液でもPETでも診断可能）

  15. 3-year change in preclinical Alzheimer Cognitive Composite (PACC) in Japanese elderly based on J-ADNI1 data (Donohue, Iwata and Iwatsubo)

  16. J-ADNI2/AMED preclinical AD Study(PI Hiroshi Mori, Osaka City U) Failure of DMT trials in AD dementia early Preclinical AD late Normal MCI AD • Consists of two observational studies:(1)Preclinical AD (n=150) screened by amyloid PET, 3-y follow up (2) early (n=100) /late MCI (n=100) studies using protocols compatible to NA ADNI2/3; implementing FCSRT, E-Cog • ~30 clinical sites, totally covered by 11C-PiB, florbetapir or flutemetamol, at ~25 PET centers nationwide • 3T MRI (including resting fMRI, ASL, DTI) • CSF examination at baseline, 12M and 36M • Towards successful clinical trials of DMTs in prodromal/preclinical AD; setting the basis for Trial Ready Cohort, providing data/mechanism for “funnel” to select at risk individuals for AD J-ADNI2/preclinical

  17. J-DCS (Japanese Dementia Clinical study Support organization) toward trials for disease modifying therapies and establishing Trial Ready Cohort funded by AMED 2016-2020 Model Clinical Studies J-DCS providing support to clinical studies and trials on AD/dementia Study Management Data registration Clinical study operation center Imaging Osaka City Univ MRI: NCNP PET: IBRI Support analysis Data management Cloud DB (CS square) database Project management Biomarkers Public Private Partnership PI Mike Weiner International Collaboration The Univ Tokyo The Univ Tokyo JADNI2/AMED preclinical DIAN-J observational Niigata biosample repository A4 study JADNI2/AMED preclinical Pharma-sponsored clinical trials QMS Cognitive scales Sperling Bateman Aisen The Univ Tokyo The Univ Tokyo The Univ Tokyo Trial Ready Cohort GAP TRC PAD/ JPAD int’l risk algorithm WG Osaka City Univ Risk evaluation funnel Iwata Iwatsubo certification study support Participation in multicenter studies Patient Registries (IROOP-NCNP, Orange Platform-NCGG) Network of ~40 clinical sites through J-ADNI and J-ADNI2/preclinical AD studies

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