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Target product profiles for treatments to delay or prevent symptomatic Alzheimer’s disease

Nature Medicine (2026)Cite this article

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Abstract

Despite advances in understanding the mechanisms, risk factors and treatment strategies for Alzheimer’s disease (AD), no approved therapies exist to prevent or delay onset in at-risk individuals or those with elevated biomarkers who do not yet show symptoms. Multiple candidate interventions are now being evaluated in clinical trials in these settings, raising key questions around which populations are most appropriate and what criteria should guide regulatory and clinical decision-making. Data are expected within 1–2 years, underscoring the need for stakeholder alignment on clinically meaningful and acceptable characteristics of preventative therapies or other products. To address this need, the Global CEO Initiative on Alzheimer’s Disease convened an international group of experts to develop target product profiles for therapies designed to delay or prevent the onset of clinical symptoms in AD. These target product profiles outline minimum and preferred characteristics, including intended use, target populations, safety expectations and efficacy benchmarks. This effort provides a foundational framework to accelerate therapeutic development and guide researchers, regulators and patients in the evaluation of emerging therapies for preventing symptomatic AD.

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References

  1. World Health Organization. Global status report on the public health response to dementia. https://www.who.int/publications/i/item/9789240033245 (2021).

  2. 2024 Alzheimer’s disease facts and figures. Alzheimers Dement. 20, 3708–3821 (2024).

  3. Nichols, E. et al. Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health 7, e105–e125 (2022).

    Article  Google Scholar 

  4. Gustavsson, A. et al. Global estimates on the number of persons across the Alzheimer’s disease continuum. Alzheimers Dement. 19, 658–670 (2023).

    Article  PubMed  Google Scholar 

  5. Kelley, A. S., McGarry, K., Gorges, R. & Skinner, J. S. The burden of health care costs for patients with dementia in the last 5 years of life. Ann. Intern. Med. 163, 729–736 (2015).

    Article  PubMed  PubMed Central  Google Scholar 

  6. Settje, K. L. P., Yap, T. L., Chapman, S., Brooks, K. & Sabol, V. K. Implementation of nurse-led cognitive screening during Medicare annual wellness visits. Nurse Pract. 18, 516–521 (2022).

    Article  Google Scholar 

  7. Nandi, A. et al. Global and regional projections of the economic burden of Alzheimer’s disease and related dementias from 2019 to 2050: a value of statistical life approach. EClinicalMedicine 51, 101580 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  8. Fowler, N. R. et al. Implementing early detection of cognitive impairment in primary care to improve care for older adults. J. Intern. Med. 298, 31–45 (2025).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Livingston, G. et al. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet 404, 572–628 (2024).

    Article  PubMed  Google Scholar 

  10. Baker, L. D. et al. Structured vs self-guided multidomain lifestyle interventions for global cognitive function: the US POINTER randomized clinical trial. JAMA 334, 681–691 (2025).

    Article  PubMed  PubMed Central  Google Scholar 

  11. Rippe, J. M. Lifestyle strategies for risk factor reduction, prevention, and treatment of cardiovascular disease. Am. J. Lifestyle Med. 13, 204–212 (2019).

    Article  PubMed  Google Scholar 

  12. Jack, C. R. Jr. et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association Workgroup. Alzheimers Dement. 20, 5143–5169 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  13. US Food and Drug Administration. Early Alzheimer’s disease: developing drugs for treatment. Guidance for industry. FDA https://www.fda.gov/media/110903/download (2024).

  14. Jack, C. R. Jr. et al. NIA-AA Research Framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 14, 535–562 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  15. Hansson, O. Biomarkers for neurodegenerative diseases. Nat. Med. 27, 954–963 (2021).

    Article  CAS  PubMed  Google Scholar 

  16. Mattke, S. et al. Health economic considerations in the deployment of an Alzheimer’s prevention therapy. J. Prev. Alzheimer. Dis. 11, 303–309 (2024).

    Article  CAS  Google Scholar 

  17. Eli Lilly and Company. Kisunla. Prescribing information. https://uspl.lilly.com/kisunla/kisunla.html#pi (2024).

  18. Eisai & Biogen. Leqembi. Prescribing information. https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf (2023).

  19. Selkoe, D. J. The advent of Alzheimer treatments will change the trajectory of human aging. Nat. Aging 4, 453–463 (2024).

    Article  CAS  PubMed  Google Scholar 

  20. Reiman, E. M. et al. A path to preventing cognitive impairment due to Alzheimer’s disease: initiatives beginning in the USA. Lancet Neurol. 25, 268–278 (2026).

    Article  PubMed  Google Scholar 

  21. Alzheimer’s Prevention Accelerator. Accelerating alzheimer’s prevention: a global imperative. Squarespace https://static1.squarespace.com/static/6729302c70a0c23130595fe3/t/678a90752731c5708b1461ce/1737134201069/Alzheimer%27s+Prevention+Accelerator+-+Final+2024+Report.pdf (2024).

  22. Cummings, J. L. et al. Alzheimer’s disease drug development pipeline: 2025. Alzheimers Dement. 11, e70098 (2025).

    Google Scholar 

  23. Bateman, R. J. et al. The DIAN-TU Next Generation Alzheimer’s prevention trial: adaptive design and disease progression model. Alzheimers Dement. 13, 8–19 (2017).

    Article  PubMed  Google Scholar 

  24. Rafii, M. S. et al. The AHEAD 3-45 study: design of a prevention trial for Alzheimer’s disease. Alzheimers Dement. 19, 1227–1233 (2023).

    Article  CAS  PubMed  Google Scholar 

  25. US National Library of Medicine. A donanemab (LY3002813) study in participants with preclinical Alzheimer’s disease (TRAILBLAZER-ALZ 3). ClinicalTrials.gov https://clinicaltrials.gov/study/NCT05026866 (2026).

  26. Bateman, R. J. et al. Safety and efficacy of long-term gantenerumab treatment in dominantly inherited Alzheimer’s disease: an open-label extension of the phase 2/3 multicentre, randomised, double-blind, placebo-controlled platform DIAN-TU trial. Lancet Neurol. 24, 316–330 (2025).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Reiman, E. M., Cummings, J. L., Langbaum, J. B., Mattke, S. & Alexander, R. C. A chance to prevent Alzheimer’s disease sooner than you think. Lancet Neurol. 23, 144–145 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  28. Slaoui, M. & Hepburn, M. Developing safe and effective COVID vaccines - Operation Warp Speed’s strategy and approach. N. Engl. J. Med. 383, 1701–1703 (2020).

    Article  CAS  PubMed  Google Scholar 

  29. US Department of Health and Human Services. From the factory to the frontlines: the Operation Warp Speed strategy for distributing a COVID-19 vaccine. HHS https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf

  30. World Health Organization. WHO target product profiles for COVID-19 vaccines. Revised April 2022. WHO https://cdn.who.int/media/docs/default-source/blue-print/tpp-6apr-2022-final.pdf?sfvrsn=4f8cede5_4&download=true

  31. Demarest, J. F. et al. Antiviral target compound profile for pandemic preparedness. Nat. Rev. Drug Discov. 24, 151–152 (2025).

    Article  CAS  PubMed  Google Scholar 

  32. European Medicines Agency. Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease. EMA https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf (2018).

  33. Aisen, P. et al. The case for regulatory approval of amyloid-lowering immunotherapies in Alzheimer’s disease based on clearcut biomarker evidence. Alzheimers Dement. 21, e14342 (2025).

    Article  CAS  PubMed  Google Scholar 

  34. Petersen, K. K. et al. Predicting onset of symptomatic Alzheimer’s disease with plasma p-tau217 clocks. Nat. Med. https://doi.org/10.1038/s41591-026-04206-y (2026).

  35. Hauber, B. et al. Assessing what matters to people affected by Alzheimer’s disease: a quantitative analysis. Neurol. Ther. 12, 505–527 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  36. DiBenedetti, D. B. et al. Assessing what matters most to patients with or at risk for Alzheimer’s and care partners: a qualitative study evaluating symptoms, impacts, and outcomes. Alzheimers Res. Ther. 12, 90 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

  37. Tochel, C. et al. What outcomes are important to patients with mild cognitive impairment or Alzheimer’s disease, their caregivers, and health-care professionals? A systematic review. Alzheimers Dement. 11, 231–247 (2019).

    Google Scholar 

  38. Reisberg, B. Functional assessment staging (FAST). Psychopharmacol. Bull. 24, 653–659 (1988).

    CAS  PubMed  Google Scholar 

  39. Wang, D. et al. Longitudinal modeling of functional decline associated with pathologic Alzheimer’s disease in older persons without cognitive impairment. J. Alzheimer. Dis. 62, 855–865 (2018).

    Article  Google Scholar 

  40. Guo, Y. et al. Characterization of Alzheimer’s tau biomarker discordance using plasma, CSF, and PET. Alzheimers Res. Ther. 13, 93 (2021).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  41. Cohen, S., Cummings, J., Knox, S., Potashman, M. & Harrison, J. Clinical trial endpoints and their clinical meaningfulness in early stages of Alzheimer’s disease. J. Prev. Alzheimers Dis. 9, 507–522 (2022).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  42. Cummings, J. & Fox, N. Defining disease modifying therapy for Alzheimer’s disease. J. Prev. Alzheimers Dis. 4, 109–115 (2017).

    CAS  PubMed  PubMed Central  Google Scholar 

  43. Elhage, A. et al. Defining benefit: clinically and biologically meaningful outcomes in the next-generation Alzheimer’s disease clinical care pathway. Alzheimers Dement. 21, e14425 (2025).

    Article  PubMed  Google Scholar 

  44. Eli Lilly. Lilly’s Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer’s disease. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunla-donanemab-azbt-showed-growing-benefit-over-three (30 July 2025).

  45. Raket, L. L., Cummings, J., Moscoso, A., Villain, N. & Schöll, M. Scenarios for the long-term efficacy of amyloid-targeting therapies in the context of the natural history of Alzheimer’s disease. Alzheimers Dement. 20, 6374–6383 (2024).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  46. Packer, M. et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N. Engl. J. Med. 383, 1413–1424 (2020).

    Article  CAS  PubMed  Google Scholar 

  47. Wheeler, D. C. et al. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. Nephrol. Dial. Transplant. 35, 1700–1711 (2020).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  48. Yang, C., Wu, Y. J., Qian, J. & Li, J. J. Landscape of statin as a cornerstone in atherosclerotic cardiovascular disease. Rev. Cardiovasc. Med. 24, 373 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  49. Sims, J. R. et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA 330, 512–527 (2023).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  50. van Dyck, C. H. et al. Lecanemab in early Alzheimer’s disease. N. Engl. J. Med. 388, 9–21 (2023).

    Article  PubMed  Google Scholar 

  51. Budd Haeberlein, S. et al. Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. J. Prev. Alzheimer. Dis. 9, 197–210 (2022).

    Article  CAS  Google Scholar 

  52. Dyck, C. H. V. et al. Lecanemab in early Alzheimer’s disease. N. Engl. J. Med. 388, 9–21 (2023).

    Article  PubMed  Google Scholar 

  53. Sperling, R. A. et al. Trial of solanezumab in preclinical Alzheimer’s disease. N. Engl. J. Med. 389, 1096–1107 (2023).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  54. Dickson, S. P. et al. ‘Time Saved’ as a demonstration of clinical meaningfulness and illustrated using the donanemab TRAILBLAZER-ALZ study findings. J. Prev. Alzheimer. Dis. 10, 595–599 (2023).

    Article  CAS  Google Scholar 

  55. Tahami Monfared, A. A., Tafazzoli, A., Ye, W., Chavan, A. & Zhang, Q. Long-term health outcomes of lecanemab in patients with early Alzheimer’s disease using simulation modeling. Neurol. Ther. 11, 863–880 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  56. Tahami Monfared, A. A. et al. A path to improved Alzheimer’s care: simulating long-term health outcomes of lecanemab in early Alzheimer’s disease from the CLARITY AD trial. Neurol. Ther. 12, 863–881 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  57. Dickson, S. P. et al. “Time Saved’ calculations to improve decision-making in progressive disease studies. J. Prev. Alzheimer. Dis. 11, 529–536 (2024).

    Article  CAS  Google Scholar 

  58. Lanctot, K. et al. Measuring time saved in Alzheimer’s disease: what is a meaningful slowing of progression?. Alzheimers Dement. 11, e70081 (2025).

    Google Scholar 

  59. Mank, A. et al. Identifying relevant outcomes in the progression of Alzheimer’s disease; what do patients and care partners want to know about prognosis?. Alzheimers Dement. 7, e12189 (2021).

    Google Scholar 

  60. Willis, B. A., Penner, N., Rawal, S., Aluri, J. & Reyderman, L. Subcutaneous (SC) lecanemab is predicted to achieve comparable efficacy and improved safety compared to lecanemab IV in early Alzheimer’s disease (AD). Alzheimers Dement. 19, e082852 (2023).

    Article  Google Scholar 

  61. US National Library of Medicine. A study of remternetug (LY3372993) in participants with Alzheimer’s disease (TRAILRUNNER-ALZ 1). ClinicalTrials.gov https://www.clinicaltrials.gov/study/NCT05463731 (2025).

  62. McDade, E., Llibre-Guerra, J. J., Holtzman, D. M., Morris, J. C. & Bateman, R. J. The informed road map to prevention of Alzheimer disease: a call to arms. Mol. Neurodegener. 16, 49 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  63. Hampel, H. et al. Blood-based biomarkers for Alzheimer’s disease: Current state and future use in a transformed global healthcare landscape. Neuron 111, 2781–2799 (2023).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  64. Hansson, O. et al. The Alzheimer’s Association appropriate use recommendations for blood biomarkers in Alzheimer’s disease. Alzheimers Dement. 18, 2669–2686 (2022).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  65. Schindler, S. E. & Atri, A. The role of cerebrospinal fluid and other biomarker modalities in the Alzheimer’s disease diagnostic revolution. Nat. Aging 3, 460–462 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  66. Schindler, S. E. et al. Acceptable performance of blood biomarker tests of amyloid pathology — recommendations from the Global CEO Initiative on Alzheimer’s disease. Nat. Rev. Neurol. 20, 426–439 (2024).

    Article  CAS  PubMed  Google Scholar 

  67. Mielke, M. M. et al. Recommendations for clinical implementation of blood-based biomarkers for Alzheimer’s disease. Alzheimers Dement. 20, 8216–8224 (2024).

  68. Palmqvist, S. et al. Alzheimer’s Association Clinical Practice Guideline on the use of blood-based biomarkers in the diagnostic workup of suspected Alzheimer’s disease within specialized care settings. Alzheimers Dement. 21, e70535 (2025).

    Article  PubMed  PubMed Central  Google Scholar 

  69. US National Library of Medicine. Dominantly inherited alzheimer network trial: an opportunity to prevent dementia. A study of potential disease modifying treatments in individuals at risk for or with a type of early onset Alzheimer’s disease caused by a genetic mutation. Master Protocol DIAN-TU-001 (DIAN-TU). ClinicalTrials.gov https://clinicaltrials.gov/study/NCT01760005 (2026).

  70. US National Library of Medicine. A study of potential disease modifying treatments in individuals at risk for or with a type of early onset AD caused by a genetic mutation (DIAN-TU). ClinicalTrials.gov https://clinicaltrials.gov/study/NCT05552157 (2026).

  71. US Food and Drug Administration. Accelerated approval – expedited program for serious conditions guidance document. FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accelerated-approval-expedited-program-serious-conditions (2024).

  72. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. (Food and Drug Administration and National Institutes of Health, 2016).

  73. Schindler, S. E. et al. Using Alzheimer’s disease blood tests to accelerate clinical trial enrollment. Alzheimers Dement. 19, 1175–1183 (2023).

    Article  PubMed  Google Scholar 

  74. Henkel, C., Seibert, S. & Nichols Widmann, C. Current advances in computerized cognitive assessment for mild cognitive impairment and dementia in older adults: a systematic review. Dement. Geriatr. Cogn. Disord. 54, 109–119 (2024).

  75. Staffaroni, A. M., Tsoy, E., Taylor, J., Boxer, A. L. & Possin, K. L. Digital cognitive assessments for dementia: digital assessments may enhance the efficiency of evaluations in neurology and other clinics. Pract. Neurol. 2020, 24–45 (2020).

    Google Scholar 

  76. Polk, S. E. et al. A scoping review of remote and unsupervised digital cognitive assessments in preclinical Alzheimer’s disease. npj Digit. Med. 8, 266 (2025).

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

We acknowledge the valuable contributions of current and former global regulatory leaders from the FDA and European Medicines Agency, and input from additional pharmaceutical company experts whose insights were instrumental in shaping the development of the TPPs.

Author information

Authors and Affiliations

  1. Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, Kirk Kerkorian School of Medicine, University of Nevada at Las Vegas, Las Vegas, NV, USA

    Jeffrey L. Cummings

  2. The Institute for Molecular Medicine, Huntington Beach, CA, USA

    Michael G. Agadjanyan

  3. Johnson & Johnson, New Brunswick, NJ, USA

    Maureen Barry

  4. Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Lawrence Corey

  5. Axxium Life, Houston, TX, USA

    Rachelle Doody

  6. Pentara Corporation, Salt Lake City, UT, USA

    Suzanne Hendrix

  7. The USC Brain Health Observatory, University of Southern California, Los Angeles, CA, USA

    Soeren Mattke

  8. Clinical Memory Research Unit, Clinical Sciences Malmö, Lund University, Lund, Sweden

    Niklas Mattsson-Carlgren

  9. Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA

    Eric McDade

  10. Foundation for the National Institutes of Health, North Bethesda, MD, USA

    Joseph P. Menetski

  11. Global Alzheimer’s Platform Foundation, Washington, DC, USA

    Richard C. Mohs

  12. The Global CEO Initiative on Alzheimer’s Disease, Wayne, PA, USA

    Katherine A. Partrick, Benjamin Tiede & George Vradenburg

  13. Vaxine, Adelaide, South Australia, Australia

    Nikolai Petrovsky & Diego Silva

  14. Ann Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Dennis J. Selkoe

  15. Center for Alzheimer Research and Treatment, Mass General Brigham, Harvard Medical School, Boston, MA, USA

    Reisa A. Sperling

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Contributions

All authors contributed to the conception and writing of the paper and provided critical feedback. J.L.C., B.T., K.A.P. and G.V. were responsible for overall direction and planning.

Corresponding author

Correspondence to Jeffrey L. Cummings.

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Competing interests

J.P.M., L.C. and M.G.A. declare no competing interests. J.L.C. has provided consultation to Acadia, Acumen, ALZpath, AnnovisBio, Artery, Axsome, Biogen, Bristol Myers Squibb, Eisai, Fosun, GAP Foundation, Hummingbird Diagnostics, IGC, Janssen, Julius Clinical, Kinoxis, Lighthouse, Lilly, Lundbeck, LSP/eqt, Merck, MoCA Cognition, Novo Nordisk, NSC Therapeutics, Optoceutics, Otsuka, ReMYND, Roche, Scottish Brain Sciences, Signant Health, Simcere, sinaptica and T-Neuro pharmaceutical, assessment, and investment companies. J.L.C. is supported by NIGMS grant P20GM109025; National Institute on Aging (NIA) grants R35AG71476 and R25AG083721-01; NINDS RO1NS139383; Alzheimer’s Disease Drug Discovery Foundation (ADDF); Ted and Maria Quirk Endowment; and Joy Chambers-Grundy Endowment. S.M. serves on the board of directors of Senscio Systems and the scientific advisory boards of ALZpath and Boston Millennia Partners and has received consulting and/or speaker fees from Biogen, C2N Diagnostics, Eisai, Eli Lilly, Novartis, Novo Nordisk and Genentech/Roche. University of Southern California has research agreements, on which S.M. is principal investigator, with Biogen, C2N, Eli Lilly, Eisai and Roche/Genentech. D.J.S. is a Director of Prothena Biosciences and an ad hoc consultant to Roche and Eisai. R.D. is a full-time employee of Axxium Life. N.M.-C. has received speaker/consultancy fees from Biogen, Eli Lilly, Merck and Owkin. M.B. is an employee of Johnson & Johnson. D.S. is an employee of Vaxine Pty. N.P. is an employee of Vaxine Pty and inventor on patents relating to AD vaccines. R.C.M. is a principal investigator on NIA grant R01AG061091, receives consulting fees from Global Alzheimer’s Platform Foundation, AgeneBio and Amyriad Therapeutics, serves on the Board of Governors for Alzheimer’s Drug Discovery Foundation and the Board of Directors for Cogstate, and holds stock in Eli Lilly and Company. G.V. is the Convener of CEOi. B.T. is the Executive Director of CEOi. K.A.P. is a paid consultant for CEOi. E.M. is supported by funding from the NIA (K23AG046363, U01AG059798), the Anonymous Foundation, GHR, the Alzheimer’s Association, and institutional support, and additional research support (to the institution) has been provided by Eli Lilly, Eisai, Hoffmann-La Roche and the DIAN-TU Pharma Consortium. E.M. has participated in speaker engagements for Eisai, Neurology Live and Projects in Knowledge-Kaplan, and advisory board roles, consulting and Data Safety Monitoring Board participation have included relationships with Eli Lilly, Alnylam, Alector, Alzamend, Sanofi, AstraZeneca, Hoffmann-La Roche, Grifols, Johnson and Johnson, Vigil Neuroscience and Merck. S.B.H. is the owner and an employee of Pentara Corporation, a consulting firm that provides services to more than 30 pharmaceutical, biotech, non-profit and academic organizations involved in clinical research, including neurodegenerative and other disease areas. R.A.S. has served as a consultant or on scientific advisory boards for AbbVie, AC Immune, Acumen, Alector, Apellis, Biohaven, Bristol Myers Squibb, Genentech, Ionis, Janssen, Oligomerix, Prothena, Roche and Vaxxinity over the past 3 years, has received research funding from Eisai and Eli Lilly for public–private partnership clinical trials, and receives research grant funding from the NIA/National Institutes of Health, GHR Foundation and the Alzheimer’s Association.

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Cummings, J.L., Agadjanyan, M.G., Barry, M. et al. Target product profiles for treatments to delay or prevent symptomatic Alzheimer’s disease. Nat Med (2026). https://doi.org/10.1038/s41591-026-04305-w

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