ADNI Private Partner Scientific Board (PPSB) Update James ...

ADNI Private Partner Scientific Board (PPSB) Update James ...

ADNI Private Partner Scientific Board (PPSB) Update James Hendrix, PhD 2018 Chairperson WW ADNI Meeting July 20, 2018 PPSB: Leadership Chair Chair-elect FNIH Past PPSB Chairs * Primary project manager # Primary Partnership Development contact 2 James Hendrix, Alzheimers Association Aparna Vasanthakumar, AbbVie Michael Biarnes, Scientific Project Manager* Rosa Canet-Aviles, Scientific Program Manager

Alison Drone, Partnership Development Officer# Julie Wolf-Rodda, Senior Vice President of Development Veronika Logovinsky, Eisai Robert Dean, Eli Lilly; Susan De Santi, Piramal Pharma, Inc.; Gerald Novak, Janssen; Jesse Cedarbaum, Biogen; Adam Schwarz, Eli Lilly; Johan Luthman, Eisai; Enchi Liu, Janssen AI; Mark Schmidt, J&J; Holly Soares, Abbvie; Patricia Cole, Takeda; Eric Siemers, Eli Lilly; Bill Potter; Pete Snyder Current PPSB Partners for ADNI3 PPSB: 2018 Key Deliverables Provide advice and input from a private / philanthropy partner perspective on the ADNI 3 implementation In the pre-competitive space, evaluate needs/gaps and recommend projects or analyses that could accelerate drug development PPSB working groups interface with ADNI cores on achieving working group goals and objectives

Articulate & communicate PPSB needs to the ADNI leadership (via PPSB Core Liaisons and the ADNI PPSB Chair) 4 PPSB Working Groups & Core Liaisons PPSB Working Groups Clinical Endpoints - TBD Biofluid Biomarkers Susan De Santi, Piramal PET Endpoints - Mark Schmidt, J&J; Gregory Klein, Roche PPSB Core Liaisons 6

Clinical Core Chad Swanson, Eisai Biostatistics Core Jerry Novak, J&J PET Core Gregory Klein, Roche/ Mark Schmidt, J&J Genetics Core Aparna Vasanthakumar, AbbVie MRI Core Patricia Cole RARC Jerry Novak, J&J CONFIDENTIAL FOR PPSB PARTNER USE ONLY PET Endpoints Working Group Leads Mark Schmidt, J&J; Gregory Klein, Roche PET Endpoints Working Group Members Maria Carrillo Alzheimers Association Jesse Cedarbaum Biogen Ping Chiao Biogen Ben Newton GE Susan De SantiPiramal Patricia E Cole Adam SchwarzTakeda

Adam Fleisher Lilly Sergey Shcherbinin Lilly Vera Kiyasova Servier Andrew Stephens Piramal Hartmuth KolbJ&J Joyce Suhy Bioclinica Johan Luthman Eisai Cyrille Sur Merck Tim McCarthy Pfizer Ivonne Suridjan AbbVie Paul McQuadeTakeda Mark Mintun Lilly Gary Tong Lundbeck Robby Weimer Genentech PET Endpoints Working Group: Goals for 2018 Work with the ADNI PET Core to support execution of the ADNI3 grant Work with the PPSB and ADNI PET Core on feasibility for collection of longitudinal early frame amyloid (EFA) PET

Assist in defining requirements, budget, sponsorship, and scope for EFA add-on to ADNI3 8 Scientific Goals: Why EFA in ADNI3? Opportunity to collect longitudinal data Companies are interested in a neurodegeneration biomarker (i.e. FDG) Cost, participant and site burden, and additional radiation exposure make it difficult Florbetaben No existing EFA data on this tracer in ADNI, and no longitudinal EFA data Potential for comparison to Arterial Spin Labelling MRI (~50% of sites are capable) ASL can be difficult to implement in clinical trials Superior S/N ratio with EFA ADNI3 EFA Proposal 200 subjects 100 florbetapir, 100 florbetaben 2 time points for each subject (2 years apart) 400 scans

Same acquisition parameters as in ADNI 2 (0-20 min, dynamic data for EFA followed by 50-70 min for the late acquisition) Stratify to balance normal/MCI/AD All data to be publicly available at LONI per standard ADNI practice FNIH is currently fund raising for the EFA proposal Lead Biofluid Biomarkers Working Group BBWG Working Group Members Susan De Santi, Piramal Imaging Richard Batrla Tobias Bittner Britta Brix Jesse Cedarbaum Jeffrey Dage Kevin Davies Susan De Santi Patricia E Cole Arnaud Francois Just Genius

Cecilia Gracia James Hendrix Lee Honigberg Dominik Jaeger Sungmin Kang June Kaplow Omar Laterza Johan Luthman Thomas Misko Laura Nisenbaum Jerry Novak Pedro Pesini Roche Roche Euroimmun Biogen Lilly Upenn Piramal Independent Servier Abbvie Servier Alzheimer's Association Genentech Euroimmun

Peoplebio Eisai Merck Eisai Abbvie Biogen J&J Araclon William Potter NIH Maria Quinton Takeda Herve Rhinn Alector Sal Salamone Saladax Mary Savage Merck Kimberly Scearce-Levie Denali Les Shaw UPenn Kira Sheinerman Diamirbio Ian Sherriff Araclon Helle Sickmann Lundbeck

Holly Soares Abbvie Cyrille Sur Merck Gary Tong Lundbeck Jan Torleif Pedersen Lundbeck John Trojanowski UPenn Iswariya Venkataraman Euroimmun Todd Walbrun Euroimmun Hong Wang Lilly Kristin Wildsmith Genentech Stephen Zicha Takeda BBWG update on CSF Residual Samples Companies provide specific aims and power calculations Company meetings discuss specific aims and

power calculations List of available samples with clinical data* (via Mike Donohue) provided to Laurel for randomization *Baseline 1 dx; decliner/stable Revision of aims/power calculations (if necessary) and resubmission Laurel Beckett randomly identifies samples of interest/company and provides the list to Les for retrieval

Finalization and approval of specific aims and sample size Samples pulled, packaged and sent to companies, Completed on Oct. 24, 2017 Final letter and protocol from LOI company; Sign off and formal FNIH letter to LOI companies LOI companies perform assays Data uploaded onto LONI website MSD completed assay analysis EI work on refernce Saladax sent letter to

clarify sample request Mike Donohue provides subject ID for uploaded CSF samples to companies to retrieve additional data Company do analyses; present data to PPSB Leads Clinical Endpoints Working Group PET Endpoints Working Group Members Currently in Discussion Previous: Veronika Logovinsky, Eisai Bruce Albala Bill Billing

Tobias Bittner Rebecca Evans Adam Fleisher Enchi Liu Johan Luthman Nuno Mendonca Richard Mohs Jerry Novak Pike Pontecorvo Nandini Raghavan Michael Ropacki Arthur Simen Chang-Heok Soh Chad Swanson Eisai Pfizer Roche Takeda Lilly Janssen Eisai Abbvie Lilly Janssen Lilly Janssen

Janssen Takeda roche Eisai Erika Tarver Jingping Wang Mike Ward Alette Wessels Lu Xu Peng Yu Xin Zhao NIA Eisai Genentech Lilly Eisai Lilly Janssen Summary of the ADNI3 Cohort with the Cogstate Brief Battery The PPSB WG: Established the ADNI2 Pilot study, then reviewed and evaluated the pilot data. The WG supported the inclusion of the Cogstate Brief Battery in ADNI3. WG members worked on the study design with both CogState and the ADCS, later ATRI.

The ADNI3 sample who have completed the Cogstate battery is continuing to grow, with 396 participants completing a baseline assessment this is an increase from 261 participants who had completed at least one assessment in ADNI3 as of March 5, 2018. When combined across both ADNI2 and ADNI3, 443 participants have completed a baseline assessment to-date. Those ADNI2 and ADNI3 subjects who have been completing the Cogstate battery for the longest period of time are now up to their Month 33 assessment. Only 194 of the 396 (49.5%) subjects in the ADNI3 sample who have completed an in-clinic baseline assessment have also completed the scheduled at-home assessment within 4 weeks of their baseline assessment. This proportion is lower than what was observed in ADNI2 (79.2%). This lower proportion of at-home follow-up assessments within the first 4 weeks of the ADNI3 baseline is consistent with what was observed in the previous analysis in March 2018. PPSB Contributions to ongoing Genetics Core Analysis Aparna Vasanthakumar, AbbVie 15 Contributions of the PPSB to the Epigenetics Initiative within the ADNI Genetics Core There is broad literature support for the potential use of DNA methylation as a marker of disease occurrence/progression To address peripheral DNA methylation changes in a large cohort of individuals, AbbVie, Biogen, and Janssen came together with Andy Saykin (Indiana

University) and the Genetics core to fund and perform the DNA methylation analyses on a subset of ADNI individuals 650 individuals were selected, a subset of who had longitudinal visits, and a total of 1720 samples were analyzed for DNA methylation changes. Data have been deposited on LONI Cross-sectional analysis of these data have been performed Several differentially methylated positions lie within loci of genes demonstrated to be associated with AD (e.g. BDNF) Results are being presented at AAIC, and being submitted as a manuscript for publication Longitudinal changes in DNA methylation are currently being analyzed RARC Update Gerald Novak, J&J 17 Resource Allocation Review Committee (RARC) Requests for genetic materials (DNA, RNA, PBMCs, etc) will now be reviewed by a separate RARC at the National Cell Repository for Alzheimers Disease (NCRAD) at Indiana University, where they are stored. o The current RARC led by Tom Montine will continue to handle biofluid requests

A separate RARC for postmortem tissues is proposed New guidance and application forms are under review and will be available on the redesigned LONI website A sample selection form will link the online application with the ADNI aliquot inventory of samples and timepoints which will help the applicant judge the feasibility of their request. Criteria for judging applications will be the same: scientific quality and value to the field; avoidance of duplication of existing studies; demonstration of ability to carry out the research; and impact on existing inventories 18 Contact Information For Scientific Inquiries: For Partnership Development Inquiries: Michael Biarnes, MS Scientific Project Manager, Neuroscience Foundation for the NIH 301.594.2612 [email protected] Alison Drone Partnership Development Officer Foundation for the NIH 301.443.2103 [email protected]

Rosa Canet-Aviles, Ph.D Scientific Program Manager, Neuroscience Foundation for the NIH 301.402.5346 [email protected] Julie Wolf-Rodda Senior Vice President of Development Foundation for the NIH 301.402.6027 [email protected] Foundation for the National Institutes of Health 11400 Rockville Pike, Suite 600 North Bethesda, MD 20852

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