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. 2023 May;19(5):1938-1946.
doi: 10.1002/alz.12843. Epub 2022 Nov 14.

A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial

Eric M Reiman  1   2 , Jeremy J Pruzin  1   2 , Silvia Rios-Romenets  3 , Chris Brown  1 , Margarita Giraldo  3 , Natalia Acosta-Baena  3 , Carlos Tobon  3 , Nan Hu  4 , Yinghua Chen  1 , Valentina Ghisays  1 , Jessica Enos  1 , Dhruman D Goradia  1 , Wendy Lee  1 , Ji Luo  1 , Michael Malek-Ahmadi  1 , Hillary Protas  1 , Ronald G Thomas  5 , Kewei Chen  1 , Yi Su  1 , Connie Boker  1 , Diego Mastroeni  6 , Sergio Alvarez  7 , Yakeel T Quiroz  8 , Jessica B Langbaum  1   2 , Kaycee M Sink  4 , Francisco Lopera  3 , Pierre N Tariot  1   2 ; API ADAD Colombia Trial Group
Affiliations

A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial

Eric M Reiman et al. Alzheimers Dement. 2023 May.

Abstract

Introduction: The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data.

Methods: We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data.

Results: Baseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers.

Discussion: Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition.

Keywords: Alzheimer's disease; amyloid; antibody; data sharing; magnetic resonance imaging; positron emission tomography; presenilin 1; primary prevention; secondary prevention.

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Conflict of interest statement

Dr. Reiman reports grants from the NIA (RF1AG041705, R01AG05544, P30AG19610, P30AG072980), Banner Alzheimer’s Foundation, and the NOMIS Foundation and is a scientific advisor to scientific advisor to Alzheon, Aural Analytics, Denali, Green Valley, Retromer Therapeutics, and Vaxxinity. He has research agreements with Genentech/Roche and Avid/Lilly. He is the co-founder, advisor, and shareholder in ALZPath. Dr. Pruzin receives research support from the Alzheimer’s Association (AACSF-20-685828), The State of Arizona (Arizona Alzheimer’s Consortium), and The Banner Health Foundation. Drs. Lopera, Rios-Romenets, Giraldo, Acosta-Baena, and Tobon report participation in other projects financed by the National Institutes of Health, Comité para el Desarrollo de la Investigación, and COLCIENCIAS. Dr. Quiroz reports grants from the NIH Office of the Director (DP5OD019833), the NIHNIA (R01AG054671), the Alzheimer’s Association, and Massachusetts General Hospital ECOR. Dr. Langbaum reports grants from NIA (RF1AG041705-01A1, P30AG072980, R01AG05544) and received consulting fees from Alector, Biogen, Denovo Biopharma, and Provoc. Banner Health has received research support from Genentech/Roche, Banner Alzheimer’s Foundation, FIL, Nomis Foundation, and the State of Arizona (Arizona Alzheimer’s Consortium). Dr. Thomas has received consulting fees from Toyama, Avraham, Intel-Genx, and Biogen. He has received research support from the National Institute on Aging. Dr. Chen is supported by grants from the National Institue on Aging ((RF1AG041705, R01AG05544, P30AG19610, P30AG072980) and is a paid consultant to Green Valley Pharmaceutical, Shanghai China, is an adjunct Professor at Beijing Normal University, China and a paid consultant of Prothena, CA. Dr. Su was supported by NIH grants R01AG031581, R01AG069453, P30AG019610, R01AG055444, R01AG058468, U19AG024904, R42AG053149, R21AG065942, Alzheimer's Association AARG17532945, BrightFocus Foundation ADR A2017272S and Arizona Department of Health Services (ADHS) and the State of Arizona, ADHS Grant No. CTR040636. Drs. Hu and Sink are full-time employees of Genentech, Inc., a member of the Roche Group and own stock in Roche. Dr. Tariot reports grants from the NIA (RF1 AG041705-01A1, R01 AG055444,1R01AG058468) and received consulting fees from AbbVie, AC Immune, Acadia, Axsome, Biogen, BioXcel, Cortexyme, Eisai, Genentech, Otsuka & Astex, Merck & Co., Novo Nordisk, Syneos and T3D Therapeutics. Until 2020, he owned shares in Adamas Pharmaceuticals. Banner Health has received research support from Genentech/Roche, Novartis, Eli Lilly & Co., Banner Alzheimer’s Foundation, FIL, Nomis Foundation, and the State of Arizona (Arizona Alzheimer’s Consortium). He is a contributor to a patent owned by the University of Rochester, U.S. Patent # 11/632,747, “Biomarkers of Neurodegenerative disease.” The authors report no further potential conflicts of interest.

Figures

Figure 1.
Figure 1.. API ADAD Trial baseline data sharing process and data recipient requirements.
Figure 2.
Figure 2.. API ADAD Trial baseline data request, review, approval, transfer, analysis, and publishing process.
This process map offers a visual representation of the cycle a formal request follows for request, review, approval, transfer, analysis and publishing. Steps are also categorized and visualized to illustrate what tasks are performed by which members of the multi-stakeholder collaboration that is required for public sharing of a public-private FDA regulated clinical trial data and imaging.
See this image and copyright information in PMC

References

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