Gantenerumab for early Alzheimer’s disease: a systematic review and meta-analysis

References

• Jack CR, 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. doi: 10.1016/j.jalz.2018.02.018
   PubMed Web of Science ®Google Scholar
• Lyketsos CG, Carrillo MC, Ryan JM, et al. Neuropsychiatric symptoms in Alzheimer’s disease. Alzheimers Dement. 2011;7(5):532–539. doi: 10.1016/j.jalz.2011.05.2410
   PubMedGoogle Scholar
• Braak H, Thal DR, Ghebremedhin E, et al. Stages of the pathologic process in Alzheimer disease: age categories from 1 to 100 years. J Neuropathol Exp Neurol. 2011;70(11):960–969. doi: 10.1097/NEN.0b013e318232a379
   PubMed Web of Science ®Google Scholar
• McKhann G, Drachman D, Folstein M, et al. Clinical diagnosis of Alzheimer’s disease: Report of the NINCDS‐ADRDA Work Group* under the auspices of department of health and human services task force on Alzheimer’s Disease. Neurology. 1984;34(7):939–939. doi: 10.1212/WNL.34.7.939
   PubMed Web of Science ®Google Scholar
• Thal DR, Rub U, Orantes M, et al. Phases of Aβ-deposition in the human brain and its relevance for the development of AD. Neurology. 2002;58(12):1791–1800. doi: 10.1212/WNL.58.12.1791
   PubMed Web of Science ®Google Scholar
• Dubois B, Feldman HH, Jacova C, et al. Revising the definition of Alzheimer’s disease: a new lexicon. Lancet Neurol. 2010;9(11):1118–1127. doi: 10.1016/S1474-4422(10)70223-4
   PubMed Web of Science ®Google Scholar
• Nelson PT, Braak H, Markesbery WR. Neuropathology and cognitive impairment in Alzheimer disease: a complex but coherent relationship. J Neuropathol Exp Neurol. 2009;68(1):1–14. doi: 10.1097/NEN.0b013e3181919a48
   PubMed Web of Science ®Google Scholar
• Gauthier SG. Alzheimer’s disease: the benefits of early treatment. Eur J Neurol. 2005;12:11–16. doi: 10.1111/j.1468-1331.2005.01322.x
   PubMed Web of Science ®Google Scholar
• Isaacson RS, Ganzer CA, Hristov H, et al. The clinical practice of risk reduction for Alzheimer’s disease: a precision medicine approach. Alzheimers Dement. 2018;14(12):1663–1673. doi: 10.1016/j.jalz.2018.08.004
   PubMed Web of Science ®Google Scholar
• Sperling RA, Aisen PS, Beckett LA, et al. Toward defining the preclinical stages of Alzheimer’s disease: recommendations from the national institute on Aging‐Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):280–292. doi: 10.1016/j.jalz.2011.03.003
   PubMed Web of Science ®Google Scholar
• Jack CR, Knopman DS, Weigand SD, et al. An operational approach to National institute on aging–alzheimer’s association criteria for preclinical Alzheimer disease. Ann Neurol. 2012;71(6):765–775. doi: 10.1002/ana.22628
   PubMed Web of Science ®Google Scholar
• Sperling R, Salloway S, Brooks DJ, et al. Amyloid-related imaging abnormalities in patients with Alzheimer’s disease treated with bapineuzumab: a retrospective analysis. Lancet Neurol. 2012;11(3):241–249. doi: 10.1016/S1474-4422(12)70015-7
   PubMed Web of Science ®Google Scholar
• Salloway S, Sperling R, Fox NC, et al. Two phase 3 trials of Bapineuzumab in mild-to-moderate Alzheimer’s disease. N Engl J Med. 2014;370(4):322–333. doi: 10.1056/NEJMoa1304839
   PubMed Web of Science ®Google Scholar
• 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;370(4):311–321. doi: 10.1056/NEJMoa1312889
   PubMed Web of Science ®Google Scholar
• Vandenberghe R, Rinne JO, Boada M, et al. Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016;8(1):18. doi: 10.1186/s13195-016-0189-7
   PubMedGoogle Scholar
• Rauchenberger R, Borges E, Thomassen-Wolf E, et al. Human combinatorial fab library yielding specific and functional antibodies against the human fibroblast growth factor receptor 3. J Biol Chem. 2003;278(40):38194–38205. doi: 10.1074/jbc.M303164200
   PubMed Web of Science ®Google Scholar
• Bohrmann B, Baumann K, Benz J, et al. Gantenerumab: a novel human anti-Aβ antibody demonstrates sustained cerebral amyloid-β binding and elicits cell-mediated removal of human amyloid-β. J Alzheimers Dis. 2012;28(1):49–69. doi: 10.3233/JAD-2011-110977
   PubMed Web of Science ®Google Scholar
• Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339(jul21 1):b2535–b2535. doi: 10.1136/bmj.b2535
   PubMed Web of Science ®Google Scholar
• Bateman RJ, Smith J, Donohue MC, et al. Two Phase 3 trials of gantenerumab in early Alzheimer’s Disease. N Engl J Med. 2023;389:1862–1876. doi: 10.1056/NEJMoa2304430
   PubMed Web of Science ®Google Scholar
• Ostrowitzki S, Lasser RA, Dorflinger E, et al. for the SCarlet RoAD Investigators. A phase III randomized trial of gantenerumab in prodromal Alzheimer’s disease. Alzheimers Res Ther. 2017;9(1):95. doi: 10.1186/s13195-017-0318-y
   PubMedGoogle Scholar
• Hardy J, Selkoe DJ. The Amyloid Hypothesis of Alzheimer’s Disease: Progress and Problems on the Road to Therapeutics. Science. 2002;297(5580):353–356. doi: 10.1126/science.1072994
   PubMed Web of Science ®Google Scholar
• Komori T. Tau‐positive dial inclusions in progressive supranuclear palsy, corticobasal Degeneration and Pick’s Disease. Brain Pathol. 1999;9(4):663–679. doi: 10.1111/j.1750-3639.1999.tb00549.x
   PubMed Web of Science ®Google Scholar
• NCT04867616 A study to test the efficacy, safety, and tolerability of Bepranemab (UCB0107) in patients with mild cognitive impairment or mild Alzheimer’s disease (AD).
   Google Scholar
• NCT04619420 a study of JNJ-63733657 in participants with early Alzheimer’s disease.
   Google Scholar
• Roberts M, Sevastou I, Imaizumi Y, et al. Pre-clinical characterisation of E2814, a high-affinity antibody targeting the microtubule-binding repeat domain of tau for passive immunotherapy in Alzheimer’s disease. Acta Neuropathol Commun. 2020;8(1):13. doi: 10.1186/s40478-020-0884-2
   PubMed Web of Science ®Google Scholar
• Orgogozo J-M, Gilman S, Dartigues J-F, et al. Subacute meningoencephalitis in a subset of patients with AD after Aβ42 immunization. Neurology. 2003;61(1):46–54. doi: 10.1212/01.WNL.0000073623.84147.A8
   PubMed Web of Science ®Google Scholar
• Song C, Shi J, Zhang P, et al. Immunotherapy for Alzheimer’s disease: targeting β-amyloid and beyond. Transl Neurodegener. 2022;11(1):18. doi: 10.1186/s40035-022-00292-3
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.14283/jpad.2022.30
   PubMed Web of Science ®Google Scholar
• Arndt JW, Qian F, Smith BA, et al. Structural and kinetic basis for the selectivity of aducanumab for aggregated forms of amyloid-β. Sci Rep. 2018;8(1):6412. doi: 10.1038/s41598-018-24501-0
   PubMed Web of Science ®Google Scholar
• Sevigny J, Chiao P, Bussière T, et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature. 2016;537(7618):50–56. doi: 10.1038/nature19323
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.1038/s41591-021-01369-8
   PubMed Web of Science ®Google Scholar
• Tzeng R-C, Yang Y-W, Hsu K-C, et al. Sum of boxes of the clinical dementia rating scale highly predicts conversion or reversion in predementia stages. Front Aging Neurosci. 2022;14:1021792. doi: 10.3389/fnagi.2022.1021792
   PubMed Web of Science ®Google Scholar
• Wessels AM, Dowsett SA, Sims JR. Detecting treatment group differences in alzheimer’s disease clinical trials: a comparison of alzheimer’s disease assessment scale - cognitive subscale (ADAS-COG) and the clinical dementia rating - sum of boxes (CDR-SB). J Prev Alzheimers Dis. 2018;1–6. doi: 10.14283/jpad.2018.2
   Web of Science ®Google Scholar
• Black RS, Sperling RA, Safirstein B, et al. A Single ascending dose study of bapineuzumab in patients with Alzheimer Disease. Alzheimer Dis Assoc Disord. 2010;24(2):198–203. doi: 10.1097/WAD.0b013e3181c53b00
   PubMed Web of Science ®Google Scholar
• Carlson C, Siemers E, Hake A, et al. Amyloid‐related imaging abnormalities from trials of solanezumab for Alzheimer’s disease. Alz & Dem Diag Ass & Dis Mo. 2016;2(1):75–85. doi: 10.1016/j.dadm.2016.02.004
   PubMedGoogle Scholar
• Ferrero J, Williams L, Stella H, et al. First‐in‐human, double‐blind, placebo‐controlled, single‐dose escalation study of aducanumab (BIIB037) in mild‐to‐moderate Alzheimer’s disease. A&D Transl Res & Clin Interv. 2016;2(3):169–176. doi: 10.1016/j.trci.2016.06.002
   PubMedGoogle Scholar
• Foroutan N, Hopkins RB, Tarride J-E, et al. Safety and efficacy of active and passive immunotherapy in mild-to-moderate Alzheimer’s disease: a systematic review and network meta-analysis. Clin Invest Med. 2019;42(1):E53–E65. doi: 10.25011/cim.v42i1.32393
   PubMed Web of Science ®Google Scholar
• Penninkilampi R, Brothers HM, Eslick GD. Safety and Efficacy of Anti-amyloid-β immunotherapy in Alzheimer’s disease: a systematic review and meta-analysis. J Neuroimmune Pharmacol. 2017;12(1):194–203. doi: 10.1007/s11481-016-9722-5
   PubMed Web of Science ®Google Scholar
• Mo J, Li J, Yang Z, et al. Efficacy and safety of anti-amyloid- β immunotherapy for Alzheimer’s disease: a systematic review and network meta-analysis. Ann Clin Transl Neurol. 2017;4(12):931–942. doi: 10.1002/acn3.469
   PubMed Web of Science ®Google Scholar
• Jeong SY, Suh CH, Shim WH, et al. Incidence of amyloid-related imaging abnormalities in patients with Alzheimer disease treated with Anti–β-Amyloid Immunotherapy: a meta-analysis. Neurology. 2022;99. doi: 10.1212/WNL.0000000000201019
   Web of Science ®Google Scholar