758
Views
2
CrossRef citations to date
0
Altmetric
Review

The potential of solanezumab and gantenerumab to prevent Alzheimer’s disease in people with inherited mutations that cause its early onset

ORCID Icon, , , , , , , , , , , , , , , & ORCID Icon show all
Pages 25-35 | Received 04 Aug 2017, Accepted 05 Oct 2017, Published online: 16 Oct 2017

References

  • Alzheimer’s Association. 2016 Alzheimer’s disease facts and figures. Alzheimers Dement. 2016;12(4):459–509.
  • Tan CC, Yu JT, Wang HF, et al. Efficacy and safety of donepezil, galantamine, rivastigmine, and memantine for the treatment of Alzheimer’s disease: a systematic review and meta-analysis. J Alzheimers Dis. 2014;41(2):615–631.
  • Zhu CW, Livote EE, Scarmeas N, et al. Long-term associations between cholinesterase inhibitors and memantine use and health outcomes among patients with Alzheimer’s disease. Alzheimers Dement. 2013;9(6):733–740.
  • Schneider LS, Mangialasche F, Andreasen N, et al. Clinical trials and late-stage drug development for Alzheimer’s disease: an appraisal from 1984 to 2014. J Intern Med. 2014;275(3):251–283.
  • Panza F, Logroscino G, Imbimbo BP, et al. Is there still any hope for amyloid-based immunotherapy for Alzheimer’s disease? Curr Opin Psychiatry. 2014;27(2):128–137.
  • Medivation. Pfizer and medivation announce results from two phase 3 studies in dimebon (latrepirdine*) Alzheimer’s disease clinical development program. [cited 2017 June 15]. Avialable from: http://press.pfizer.com/press-release/pfizer-and-medivation-announce-results-two-phase-3-studies-dimebon-latrepirdine-alzhei
  • Quinn JF, Raman R, Thomas RG, et al. Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial. JAMA. 2010;304(17):1903–1911.
  • Sampson EL, Jenagaratnam L, McShane R. Metal protein attenuating compounds for the treatment of Alzheimer’s dementia. Cochrane Database Syst Rev. 2014;2:CD005380.
  • Mohs RC, Shiovitz TM, Tariot PN, et al. Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study. Am J Geriatr Psychiatry. 2009;17(9):752–759.
  • Yun HM, Rhim H. The serotonin-6 receptor as a novel therapeutic target. Exp Neurobiol. 2011;20(4):159–168.
  • Grove RA, Harrington CM, Mahler A, et al. A randomized, double-blind, placebo-controlled, 16-week study of the H3 receptor antagonist, GSK239512 as a monotherapy in subjects with mild-to-moderate Alzheimer’s disease. Curr Alzheimer Res. 2014;11(1):47–58.
  • Panza F, Seripa D, Solfrizzi V, et al. Emerging drugs to reduce abnormal β-amyloid protein in Alzheimer’s disease patients. Expert Opin Emerg Drugs. 2016;21(4):377–391.
  • Seripa D, Solfrizzi V, Imbimbo BP, et al. Tau-directed approaches for the treatment of Alzheimer’s disease: focus on leuco-methylthioninium. Expert Rev Neurother. 2016;16(3):259–277.
  • Walter J, Kaether C, Steiner H, et al. The cell biology of Alzheimer’s disease: uncovering the secrets of secretases. Curr Opin Neurobiol. 2001;11:585–590.
  • Vassar R, Kuhn PH, Haass C, et al. Function, therapeutic potential and cell biology of BACE proteases: current status and future prospects. J Neurochem. 2014;130(1):4–28.
  • D’Onofrio G, Panza F, Frisardi V, et al. Advances in the identification of γ-secretase inhibitors for the treatment of Alzheimer’s disease. Expert Opin Drug Discov. 2012;7(1):19–37.
  • Lannfelt L, Blennow K, Zetterberg H, et al. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer’s disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008;7(9):779–786.
  • Salloway S, Sperling R, Keren R, et al. A phase 2 randomized trial of ELND005, scylloinositol, in mild to moderate Alzheimer disease. Neurology. 2011;77(13):1253–1262.
  • Jack CR Jr., Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):257–262.
  • Jack CR Jr., Knopman DS, Jagust WJ, et al. Tracking pathophysiological processes in Alzheimer’s disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013;12(2):207–216.
  • Bu XL, Jiao SS, Lian Y, et al. Perspectives on the tertiary prevention strategy for Alzheimer’s disease. Curr Alzheimer Res. 2016;13(3):307–316.
  • Coric V, van Dyck CH, Salloway S, et al. Safety and tolerability of the γ-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012;69(11):1430–1440.
  • Doody RS, Raman R, Siemers E, et al. A phase 2 trial of semagacestat for treatment of Alzheimer’s disease. N Engl J Med. 2013;369(4):341–350.
  • 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.
  • 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.
  • Panza F, Solfrizzi V, Imbimbo BP, et al. Amyloid-based immunotherapy for Alzheimer’s disease in the time of prevention trials: the way forward. Expert Rev Clin Immunol. 2014;10(3):405–419.
  • 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.
  • Dubois B, Feldman HH, Jacova C, et al. Research criteria for the diagnosis of Alzheimer’s disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007;6(8):734–746.
  • Solomon A, Mangialasche F, Richard E, et al. Advances in the prevention of Alzheimer’s disease and dementia. J Intern Med. 2014;275(3):229–250.
  • Andrieu S, Coley N, Lovestone S, et al. Prevention of sporadic Alzheimer’s disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015;14(9):926–944.
  • Huang Y, Mucke L. Alzheimer mechanisms and therapeutic strategies. Cell. 2012;148(6):1204–1222.
  • Bertram L, Tanzi RE. Thirty years of Alzheimer’s disease genetics: the implications of systematic meta-analyses. Nat Rev Neurosci. 2008;9(10):768–778.
  • Bateman RJ, Aisen PS, De Strooper B, et al. Autosomal-dominant Alzheimer’s disease: a review and proposal for the prevention of Alzheimer’s disease. Alzheimers Res Ther. 2011;3(1):1.
  • Hinerfeld DA, Moonis M, Swearer JM, et al. Statins differentially affect amyloid precursor protein metabolism in presymptomatic PS1 and non-PS1 subjects. Arch Neurol. 2007;64(11):1672–1673.
  • Morris JC, Aisen PS, Bateman RJ, et al. Developing an international network for Alzheimer research: the dominantly inherited Alzheimer network. J Clin Invest. 2012;2(10):975–984.
  • Mills SM, Mallmann J, Santacruz AM, et al. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013;169(10):737–743.
  • Lemere CA. Immunotherapy for Alzheimer’s disease: hoops and hurdles. Mol Neurodegener. 2013;8:36.
  • Bard F, Cannon C, Barbour R, et al. Peripherally administered antibodies against amyloid β-peptide enter the central nervous system and reduce pathology in a mouse model of Alzheimer disease. Nat Med. 2000;6(8):916–919.
  • Morgan D. Mechanisms of A beta plaque clearance following passive A beta immunization. Neurodegener Dis. 2005;2(5):261–266.
  • Panza F, Frisardi V, Imbimbo BP, et al. Anti-β-amyloid immunotherapy for Alzheimer’s disease: focus on bapineuzumab. Curr Alzheimer Res. 2011;8(8):808–817.
  • Imbimbo BP, Ottonello S, Frisardi V, et al. Solanezumab for the treatment of mild-to-moderate Alzheimer’s disease. Expert Rev Clin Immunol. 2012;8(2):135–149.
  • Tayeb HO, Murray ED, Price BH, et al. Bapineuzumab and solanezumab for Alzheimer’s disease: is the ‘amyloid cascade hypothesis’ still alive? Expert Opin Biol Ther. 2013;13(7):1075–1084.
  • Wang J, Tan L, Yu JT. Prevention trials in Alzheimer’s disease: current status and future perspectives. J Alzheimers Dis. 2016;50(4):927–945.
  • Reiman EM, Langbaum JB, Tariot PN. Alzheimer’s prevention initiative: a proposal to evaluate presymptomatic treatments as quickly as possible. Biomark Med. 2010;4:3–14.
  • Reiman EM, Langbaum JB, Tariot PN, et al. CAP–advancing the evaluation of preclinical Alzheimer disease treatments. Nat Rev Neurol. 2016;12(1):56–61.
  • Sperling RA, Rentz DM, Johnson KA, et al. The A4 study: stopping AD before symptoms begin? Sci Transl Med. 2014;6(228):228fs13.
  • Reiman EM, Langbaum JB, Fleisher AS, et al. Alzheimer’s prevention initiative: a plan to accelerate the evaluation of presymptomatic treatments. J Alzheimers Dis. 2011;26(Suppl 3):321–329.
  • Guidance for industry. Alzheimer’s disease: developing drugs for the treatment of early stage disease. Draft guidance. FDA. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm338287.pdf
  • European Medicines Agency. Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176827.pdf
  • DeMattos RB, Racke MM, Gelfanova V, et al. Identification, characterization, and comparison of amino-terminally truncated Aβ42 peptides in Alzheimer’s disease brain tissue and in plasma from Alzheimer’s patients receiving solanezumab immunotherapy treatment. Alzheimers Dement. 2009;5(Supplement 4):P156-157(O4-04-02).
  • Siemers ER, Friedrich S, Dean RA, et al. Safety and changes in plasma and cerebrospinal fluid amyloid-beta after a single administration of an amyloid-beta monoclonal antibody in subjects with Alzheimer disease. Clin Neuropharmacol. 2010;33(2):67–73.
  • Farlow M, Arnold SE, van Dyck CH, et al. Safety and biomarker effects of solanezumab in patients with Alzheimer’s disease. Alzheimers Dement. 2012;8(4):261–271.
  • Lilly announces top-line results of solanezumab phase 3 clinical trial. [cited 2017 Sep 20]. Available from: https://investor.lilly.com/releasedetail.cfm?ReleaseID=1000871
  • Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to 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):270–279.
  • Donohue MC, Sperling RA, Salmon DP, et al. Australian Imaging, Biomarkers, and Lifestyle Flagship Study of Ageing, Alzheimer’s Disease Neuroimaging Initiative, Alzheimer’s Disease Cooperative Study. The preclinical Alzheimer cognitive composite: measuring amyloid-related decline. JAMA Neurol. 2014;71(8):961–970.
  • Jack CR Jr, Knopman DS, Weigand SD, et al. An operational approach to NIA–AA criteria for preclinical Alzheimer’s disease. Ann Neurol. 2011;71(6):765–775.
  • Adolfsson O, Pihlgren M, Toni N, et al. An effector-reduced anti-b-amyloid (Ab) antibody with unique Ab binding properties promotes neuroprotection and glial engulfment of Ab. J Neurosci. 2012;32(28):9677–9689.
  • Reiman EM, Quiroz YT, Fleisher AS, et al. Brain imaging and fluid biomarker analysis in young adults at genetic risk for autosomal dominant Alzheimer’s disease in the presenilin 1 E280A kindred: a case–control study. Lancet Neurol. 2012;11(12):1048–1056.
  • Fleisher AS, Chen K, Quiroz YT, et al. Florbetapir PET analysis of amyloid-β deposition in presenilin 1 E280A autosomal-dominant Alzheimer’s disease kindred: a cross-sectional study. Lancet Neurol. 2012;11(12):1057–1065.
  • Lemere CA, Lopera F, Kosik KS, et al. The E280A presenilin 1 Alzheimer mutation produces increased Ab42 deposition and severe cerebellar pathology. Nat Med. 1996;2(10):1146–1150.
  • Lopera F, Ardilla A, Martinez A, et al. Clinical features of early-onset Alzheimer disease in a large kindred with an E280A presenilin-1 mutation. JAMA. 1997;277(10):793–799.
  • Langbaum JB, Hendrix S, Ayutyanont N, et al. Establishing composite cognitive endpoints for use in preclinical Alzheimer’s disease trials. J Prev Alzheimers Dis. 2015;2(1):2–3.
  • Panza F, Solfrizzi V, Imbimbo BP, et al. Efficacy and safety studies of gantenerumab in patients with Alzheimer’s disease. Expert Rev Neurother. 2014;14(9):973–986.
  • Bohrmann B, Baumann K, Benz J, et al. Gantenerumab: a novel human anti-Aβ antibody demonstrating sustained cerebral amyloid-β binding and elicits cell-mediated removal of human amyloid-b. J Alzheimers Dis. 2012;28(1):49–69.
  • Ostrowitzki S, Deptula D, Thurfjell L, et al. Mechanism of amyloid removal in patients with Alzheimer disease treated with gantenerumab. Arch Neurol. 2012;69(2):198–207.
  • Hoffmann-La Roche Media Release. Roche provides update on gantenerumab development programme. [cited 2017 June 15]. Available from: http://www.roche.com/media/store/releases/med-cor-2014-12-19b.htm
  • Nilsberth C, Westlind-Danielsson A, Eckman CB, et al. The ‘Arctic’ APP mutation (E693G) causes Alzheimer’s disease by enhanced Abeta protofibril formation. Nat Neurosci. 2001;4(9):887–893.
  • Sehlin D, Englund H, Simu B, et al. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014.
  • Lannfelt L, Möller C, Basun H, et al. Perspectives on future Alzheimer therapies: amyloid-β protofibrils - a new target for immunotherapy with BAN2401 in Alzheimer’s disease. Alzheimers Res Ther. 2014;6(2):16.
  • Moulder KL, Snider BJ, Mills SL, et al. Dominantly inherited Alzheimer Network: facilitating research and clinical trials. Alzheimers Res Ther. 2013;5(5):48.
  • Bateman RJ, Benzinger TL, Berry S, et al. DIAN-TU pharma consortium for the dominantly inherited Alzheimer network. The DIAN-TU next generation Alzheimer’s prevention trial: adaptive design and disease progression model. Alzheimers Dement. 2017;13(1):8–19.
  • Toyn J. What lessons can be learned from failed Alzheimer’s disease trials? Expert Rev Clin Pharmacol. 2015;8(3):267–269.
  • Bennett DA, Schneider JA, Arvanitakis Z, et al. Neuropathology of older persons without cognitive impairment from two community-based studies. Neurology. 2006;66(12):1837–1844.
  • Donohue MC, Sperling RA, Petersen R, et al. Association between elevated brain amyloid and subsequent cognitive decline among cognitively normal persons. Jama. 2017;317(22):2305–2316.
  • Morris GP, Clark IA, Vissel B. Inconsistencies and controversies surrounding the amyloid hypothesis of Alzheimer’s disease. Acta Neuropathol Commun. 2014;2:135.
  • Musiek ES, Holtzman DM. Three dimensions of the amyloid hypothesis: time, space and ‘wingmen’. Nat Neurosci. 2015;18(6):800–806.
  • Bishop GM, Robinson SR. Physiological roles of amyloid-β and implications for its removal in Alzheimer’s disease. Drugs Aging. 2004;21(10):621–630.
  • Castellani RJ, Lee HG, Zhu X, et al. Alzheimer disease pathology as a host response. J Neuropathol Exp Neurol. 2008;67(6):523–531.
  • Soldan A, Pettigrew C, Cai Q, et al. BIOCARD Research Team. Hypothetical preclinical alzheimer disease groups and longitudinal cognitive change. JAMA Neurol. 2016;73(6):698–705.
  • Maarouf CL, Daugs ID, Kokjohn TA, et al. The biochemical aftermath of anti-amyloid immunotherapy. Mol Neurodegener. 2010;5:39.
  • Hara H, Ono F, Nakamura S, et al. An oral Aβ vaccine using a recombinant adeno-associated virus vector in aged monkeys: reduction of amyloid plaques and increase of Aβ oligomers. J Alzheim Dis. 2016;54(3):1047.
  • Yamada J, Yabuki C, Seubert P, et al. Aβ immunotherapy: intracerebral sequestration of Aβ by an anti Aβ monoclonal antibody 266 with high affinity to soluble Aβ. J Neurosci. 2009;29(36):11393–11398.
  • Watts RJ, Chen M, Atwal J, et al. Selection of an anti-Aβ antibody that binds various forms of Aβ and blocks toxicity both in vitro and in vivo. Alzheimers Dement. 2009;5(4 Supplement):P426(P3-283).
  • Relkin NR. Natural human antibodies targeting amyloid aggregates in intravenous immunoglobulin. Alzheimers Dement. 2008;4(4Supplement):T101(S1-02-02).
  • Du Y, Wei X, Dodel R, et al. Human anti-β-amyloid antibodies block β-amyloid fibril formation and prevent β-amyloid-induced neurotoxicity. Brain. 2003;126(Pt 9):1935–1939.
  • Ma QL, Lim GP, Harris-White ME, et al. Antibodies against β-amyloid reduce Aβ oligomers, glycogen synthase kinase-3β activation and τ phosphorylation in vivo and in vitro. J Neurosci Res. 2006;83(3):374–384.
  • Panza F, Solfrizzi V, Lozupone M, et al. Cognitive frailty: a potential target for secondary prevention of dementia. Expert Opin Drug Metab Toxicol. 2017. [Epub ahead of print]. DOI:10.1080/17425255.2017.1372424
  • Kelaiditi E, Cesari M, Canevelli M, et al. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013;17(9):726–734.
  • Ruan Q, Yu Z, Chen M, et al. Cognitive frailty, a novel target for the prevention of elderly dependency. Ageing Res Rev. 2015;20:1–10.
  • Panza F, Seripa D, Solfrizzi V, et al. Targeting cognitive frailty: clinical and neurobiological roadmap for a single complex phenotype. J Alzheimers Dis. 2015;47:793–813.
  • Ngandu T, Lehtisalo J, Solomon A, et al. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015;385(9984):2255–2263.
  • Ruan Q, D’Onofrio G, Sancarlo D, et al. Emerging biomarkers and screening for cognitive frailty. Aging Clin Exp Res. 2017. [Epub ahead of print]. DOI:10.1007/s40520-017-0741-8
  • Jonsson T, Atwal JK, Steinberg S, et al. A mutation in APP protects against Alzheimer’s disease and age-related cognitive decline. Nature. 2012;488(7409):96–99.
  • Martiskainen H, Herukka SK, Stančáková A, et al. Decreased plasma β-amyloid in the Alzheimer’s disease APP A673T variant carriers. Ann Neurol. 2017. [Epub ahead of print]. DOI:10.1002/ana.24969

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.