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USA Alzheimer ’ s Disease Neuroimaging Initiative WORLD-WIDE ADNI

USA Alzheimer ’ s Disease Neuroimaging Initiative WORLD-WIDE ADNI. Michael W. Weiner. The “ Big ” News. The highly encouraging Biogen phase 1b results, showing reduction of brain amyloid load and slowing of cognitive decline, provide POC for anti-amyloid treatments This encourages

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USA Alzheimer ’ s Disease Neuroimaging Initiative WORLD-WIDE ADNI

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  1. USA Alzheimer’s Disease Neuroimaging InitiativeWORLD-WIDE ADNI Michael W. Weiner

  2. The “Big” News • The highly encouraging Biogen phase 1b results, showing reduction of brain amyloid load and slowing of cognitive decline, provide POC for anti-amyloid treatments • This encourages • more clinical trial activity • more NIH funding • interest in AD biomarkers detection and monitoring • Potential problems in enrolling ADNI 3 subjects

  3. THE BIG PICTURE • Overall, ADNI is doing very well • We have 15 months left for ADNI2 • Two tau PET studies funded in past year • DOD Tau PET, includes ADNI subjects • ADNI competitive supplement for tau PET • Funds tau PET on all ADNI and DOD ADNI subjects • Cogstate add-on project: at home NP testing • Paul Aisen has moved to ATRI at USC • Expect to submit ADNI3 mid October 2015

  4. PLANS FOR ADNI 3SPECIFIC AIMS Overall goal: validation of biomarkers for AD • Longitudinal change of cognition and biomarkers: measures that capture longitudinal change with highest statistical power • Prediction of cognitive decline: • Clinical trial design: Optimum outcome measures, predictors, and inclusion/exclusion criteria for clinical trials • Discovery: new markers, new targets

  5. ADNI 3 STUDY DESIGN • About 900 subjects planned • 40% cognitively normal, 40% MCI, 20% dementia (from converted MCI) • Most subjects will be roll-overs, but some new subjects will be enrolled • Annual visits: Clinical, cognitive, MRI, amyloid PET, tau PET, FDG PET?, LP/CSF, genetics, omics

  6. NEW FEATURES IN ADNI 3 • Use of Brain Health Registry for recruitment, assessment and longitudinal monitoring • Includes on-line cognitive testing for screening, F/U • Tau PET: AVID 1451, and others to be considered • Amyloid PET centaloid project: AVID, Pirimal, ? • Advanced, Connectome, multi-modal MRI • New Platform for CSF analysis, Mass Spec • Systems Biology, Omics, and Data Mining

  7. DISCLOSING RESULTS TO PATIENTS • Some clinicans request to disclose results to patients. Request change in ADNI policy • Advantages • Patients have a “right to know” • Will facilitate recruitment/retention • Disadvantages • This action will change the outcome • Not using “CLIA-approved labs” • Amyloid PET, CSF results, tau results, genetics? • Current plan is not to include in grant application

  8. PROBLEM: COMPETITIVE SPACE • Selection of ADNI 3 Biomarker platform • Review of all possibilities: consultation with PPSB • Selection of tau tracer by PET Core • Currently AVID 1451 is only tracer widely available, piloted in ADNI2 • All possible tau tracers to be considered • Selection of on-line cognitive tests • Compelling data in grant required: goal is to be funded • ADNI 3 begins 9months after grant submission • ADNI 3 enrollment will compete with many trials

  9. COLLABORATION WITH INDUSTRY PARTNERS • ADNI is a grant submitted to NIA, must be reviewed and funded • ADNI investigators responsible for scientific conduct • UO-1 or UO-19 requires close NIA oversight: For example, NIA decides on sample release • Industry supports 30% of funds. The overall goal is to facilitate industry and academic trials. We greatly value PPSB input and collaboration

  10. OTHER COLLABORATIONS • Joint analysis with DIAN • Joint analysis of ADNI and PPMI data sponsored by Michael J Fox • SAGE Challange

  11. GOVERNANCE • Grant is submitted to NIA from the Northern California Institute for Research and Education (NCIRE), Michael Weiner PI • In the event that the PI cannot function as PI, Bill Jagust , at UC Berkeley, will become PI and assume an NCIRE appointment • After that future decisions will be made by NIA, NCIRE, ADNI Executive Committee , in consultation with the PPSB

  12. LONG TERM FUTURE OF ADNI • If ADNI 3 proceeds, what would happen after ADNI 3? • Depending on success of treatments, it may not be possible to enroll subjects with preclinical, prodromal or , dementia due to AD in an observational trial • Shift to study of younger amyloid negative subjects at long term risk for developing amyloid positivity: primary prevention trials to prevent amyloid /tau formation • And/or a study of “normal aging”

  13. OPPORTUNITY • ADNI 3 may be the “last” large USA observational study of the natural history of AD progression • Availability of treatments will prevent study of populations without treatment • High excitement about AD clinical trials provides compelling rationale for ADNI3 to inform better trial design

  14. MANY THANKS • NIA for strong support • Industry Partners, Foundations, and FNIH • Site PIs, study coordinators • ADCS staff • Subjects and their families • WW ADNI studies

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