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New Biomarkers and Biological Therapies in Alzheimer’s Disease Cover

New Biomarkers and Biological Therapies in Alzheimer’s Disease

Open Access
|Jul 2025

References

  1. Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019.
  2. Colvee-Martin H, Parra JR, Gonzalez GA, et al. Neuropathology, Neuroimaging, and Fluid Biomarkers in Alzheimer’s Disease. Diagnostics (Basel). 2024;14(7):704.
  3. Jia J, Ning Y, Chen M, et al. Biomarker Changes during 20 Years Preceding Alzheimer’s Disease. N Engl J Med. 2024;390(8):712-722.
  4. Chen Y, Lai M, Tao M. Evaluating the efficacy and safety of Alzheimer’s disease drugs: A meta-analysis and systematic review. Medicine (Baltimore). 2024;103(16):e37799.
  5. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA Research Framework: Toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562.
  6. Jack CR Jr, Andrews JS, Beach TG, et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association Workgroup. Alzheimers Dement. 2024;20(8):5143-5169.
  7. Molinuevo JL, Ayton S, Batrla R, et al. Current state of Alzheimer’s fluid biomarkers. Acta Neuropathol. 2018;136(6):821-853.
  8. Karikari TK, Pascoal TA, Ashton NJ, et al. Blood phosphorylated tau 181 as a biomarker for Alzheimer’s disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. Lancet Neurol. 2020;19(5):422-433.
  9. Pandey N, Yang Z, Cieza B, et al. Plasma phospho-tau217 as a predictive biomarker for Alzheimer’s disease in a large south American cohort. Alzheimers Res Ther. 2025;17(1):1.
  10. Grande G, Valletta M, Rizzuto D, et al. Blood-based biomarkers of Alzheimer’s disease and incident dementia in the community. Nat Med. 2025.
  11. Wang J, Huang S, Lan G, et al. Diagnostic accuracy of plasma p-tau217/Aβ42 for Alzheimer’s disease in clinical and community cohorts. Alzheimers Dement. 2025 Mar;21(3):e70038.
  12. Pais MV, Forlenza OV, Diniz BS. Plasma Biomarkers of Alzheimer’s Disease: A Review of Available Assays, Recent Developments, and Implications for Clinical Practice. J Alzheimers Dis Rep. 2023 May 3;7(1):355-380.
  13. Asken BM, DeSimone JC, Wang WE, et al. Plasma p-tau217 concordance with amyloid PET among ethnically diverse older adults. Alzheimers Dement (Amst). 2024 Jul 17;16(3):e12617.
  14. Manco C, Cortese R, Leoncini M, et al. Hippocampal atrophy and white matter lesions characteristics can predict evolution to dementia in patients with vascular mild cognitive impairment. J Neurol Sci. 2024 Sep 15;464:123163.
  15. Punzi M, Sestieri C, Picerni E, et al. Atrophy of hippocampal subfields and amygdala nuclei in subjects with mild cognitive impairment progressing to Alzheimer’s disease. Heliyon. 2024;10(6):e27429.
  16. Villemagne VL, Doré V, Burnham SC, et al. Imaging tau and amyloid-β proteinopathies in Alzheimer disease and other conditions. Nat Rev Neurol. 2018;14(4):225-236. Erratum in: Nat Rev Neurol. 2018;14(7):446.
  17. Ossenkoppele R, Rabinovici GD, Smith R, et al. Discriminative Accuracy of [18F]flortaucipir Positron Emission Tomography for Alzheimer Disease vs Other Neurodegenerative Disorders. JAMA. 2018;320(11):1151-1162.
  18. Ossenkoppele R, Reimand J, Smith R, et al. Tau PET correlates with different Alzheimer’s disease-related features compared to CSF and plasma p-tau biomarkers. EMBO Mol Med. 2021 Aug 9;13(8):e14398. doi: 10.15252/emmm.202114398. Epub 2021 Jul 13. PMID: 34254442; PMCID: PMC8350902.
  19. Belloy ME, Andrews SJ, Le Guen Y, et al. APOE Genotype and Alzheimer Disease Risk Across Age, Sex, and Population Ancestry. JAMA Neurol. 2023;80(12):1284-1294.
  20. Sun YY, Wang Z, Huang HC. Roles of ApoE4 on the Pathogenesis in Alzheimer’s Disease and the Potential Therapeutic Approaches. Cell Mol Neurobiol. 2023;43(7):3115-3136.
  21. Nan H, Chu M, Jiang D, et al. Identification and characterization of variants in PSEN1, PSEN2, and APP genes in Chinese patients with early-onset Alzheimer’s disease. Alzheimers Res Ther. 2025;17(1):54.
  22. Liang J, Hussainy S, Lee SM, et al. Association of Polygenic Risk Score for 5 Diseases With Alzheimer Disease Progression, Biomarkers, and Amyloid Deposition. Neurology. 2025;104(4):e210250.
  23. Wu W, Ji Y, Wang Z, et al. The FDA-approved anti-amyloid-β monoclonal antibodies for the treatment of Alzheimer’s disease: a systematic review and meta-analysis of randomized controlled trials. Eur J Med Res. 2023;28(1):544.
  24. Budd Haeberlein S, Aisen PS, Barkhof F, et al. Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease. J Prev Alzheimers Dis. 2022;9(2):197-210.
  25. Bobbins A, Davies M, Lynn E, et al. Safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer’s disease: The pharmacovigilance perspective. Br J Clin Pharmacol. 2025;91(5):1352-1360.
  26. Yakushev I, Verger A, Brendel M, et al. Lecanemab approval in EU: what should we be ready for? – the EANM perspective. Eur J Nucl Med Mol Imaging. 2025;52(5):1607-1610.
  27. Martorana A, Bonomi CG, Di Donna MG, et al. Lecanemab’s Path Forward: Navigating the Future of Alzheimer’s Treatment in Europe Amidst the EMA’s Rejection. Neurol Ther. 2025;14(1):1-5.
  28. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer’s Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29. PMID: 36449413.
  29. Cohen S, van Dyck CH, Gee M, et al. Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer’s Disease. J Prev Alzheimers Dis. 2023;10(4):771-777.
  30. Khartabil N, Awaness A. Targeting Amyloid Pathology in Early Alzheimer’s: The Promise of Donanemab-Azbt. Pharmacy (Basel). 2025;13(1):23.
  31. Lowe SL, Duggan Evans C, Shcherbinin S, et al. Donanemab (LY3002813) Phase 1b Study in Alzheimer’s Disease: Rapid and Sustained Reduction of Brain Amyloid Measured by Florbetapir F18 Imaging. J Prev Alzheimers Dis. 2021;8(4):414-424.
  32. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527.
  33. Salloway S, Farlow M, McDade E, et al. A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer’s disease. Nat Med. 2021;27(7):1187-1196.
  34. Bittner T, Tonietto M, Klein G, et al. Biomarker treatment effects in two phase 3 trials of gantenerumab. Alzheimers Dement. 2025 Feb;21(2):e14414.
  35. Honig LS, Vellas B, Woodward M, et al. Trial of Solanezumab for Mild Dementia Due to Alzheimer’s Disease. N Engl J Med. 2018 Jan 25;378(4):321-330.
  36. Doody RS, Thomas RG, Farlow M, et al. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer’s disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889. PMID: 24450890.
  37. Wagemann O, Liu H, Wang G, et al. Downstream Biomarker Effects of Gantenerumab or Solanezumab in Dominantly Inherited Alzheimer Disease: The DIAN-TU-001 Randomized Clinical Trial. JAMA Neurol. 2024;81(6):582-593.
  38. Shulman M, Kong J, O’Gorman J, et al. TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer’s disease. Nat Aging. 2023;3(12):1591-1601.
  39. Florian H, Wang D, Arnold SE, et al. Tilavonemab in early Alzheimer’s disease: results from a phase 2, randomized, double-blind study. Brain. 2023;146(6):2275-2284.
  40. Teng E, Manser PT, Pickthorn K, et al. Safety and Efficacy of Semorinemab in Individuals With Prodromal to Mild Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2022;79(8):758-767.
  41. Vroom MM, Dodart JC. Active Immunotherapy for the Prevention of Alzheimer’s and Parkinson’s Disease. Vaccines (Basel). 2024;12(9):973.
  42. Vellas B, Black R, Thal LJ, et al. Long-term follow-up of patients immunized with AN1792: reduced functional decline in antibody responders. Curr Alzheimer Res. 2009;6(2):144-51.
  43. Yu HJ, Dickson SP, Wang PN, et al. Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer’s disease: a randomised, double-blind, placebo-controlled, phase 2a study. EBioMedicine. 2023;94:104665.
  44. Mummery CJ, Börjesson-Hanson A, Blackburn DJ, et al. Author Correction: Tau-targeting antisense oligonucleotide MAPTRx in mild Alzheimer’s disease: a phase 1b, randomized, placebo-controlled trial. Nat Med. 2024;30(1):304. Erratum for: Nat Med. 2023;29(6):1437-1447.
  45. Li Y, Xu H, Wang H, et al. TREM2: Potential therapeutic targeting of microglia for Alzheimer’s disease. Biomed Pharmacother. 2023;165:115218.
  46. Condello C, Yuan P, Grutzendler J. Microglia-Mediated Neuroprotection, TREM2, and Alzheimer’s Disease: Evidence From Optical Imaging. Biol Psychiatry. 2018;83(4):377-387.
  47. Razzaghi M, Soleymani Eil Bakhtiari S, Charest G, et al. Microneedle arrays for brain drug delivery: the potential of additive manufacturing. Trans Can Soc Mech Eng. 2025.
  48. Jönsson L, Wimo A, Handels R, et al. The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer’s disease: an EADC-EC viewpoint. Lancet Reg Health Eur. 2023 May 22;29:100657.
  49. Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the US. JAMA Neurol. 2022 May 1;79(5):478-487.
  50. Mahase E. NICE rejects Alzheimer’s drug donanemab owing to cost and “significant health risks”. BMJ. 2024 Oct 23;387:q2342.
  51. Martorana A, Bonomi CG, Di Donna MG, et al. Lecanemab’s Path Forward: Navigating the Future of Alzheimer’s Treatment in Europe Amidst the EMA’s Rejection. Neurol Ther. 2025 Feb;14(1):1-5.
  52. Wise J. Lecanemab: European drug agency upholds decision to recommend Alzheimer’s drug. BMJ. 2025 Mar 3;388:r439.
  53. Smith J, Donohue MC, Gruendl E, et al. GRADUATE I AND II: Findings of Two Phase III Randomized Placebo-controlled Studies Assessing the Efficacy and Safety of Subcutaneous Gantenerumab in Early Alzheimer’s Disease (AD) (S26.010). Neurology. 2023 Apr 25;100(17 Suppl 2).
DOI: https://doi.org/10.2478/bgbl-2025-0012 | Journal eISSN: 2956-6851 | Journal ISSN: 0373-174X
Language: English
Page range: 167 - 186
Accepted on: Jun 18, 2025
Published on: Jul 2, 2025
Published by: The Medical Library named after S. Konopka in Warsaw
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year

© 2025 Wiktoria Balcerzak, published by The Medical Library named after S. Konopka in Warsaw
This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 License.