What can triumphs and tribulations from drug research in Alzheimer's disease tell us about the development of psychotropic drugs in general?

The Lancet Psychiatry

Volumn 2, Issue 8, 2015, Pages 756-764

  Becker, Robert E ^a   Seeman, Mary V ^c   Greig, Nigel H ^b   Lahiri, Debomoy K ^d  

^a Aristea Translational Medicine Corporation   (United States)

^b NATIONAL INSTITUTE ON AGING   (United States)

^c UNIVERSITY OF TORONTO   (Canada)

^d INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORPROMAZINE; CLOZAPINE; IMIPRAMINE; IPRONIAZID; LITHIUM; MEMANTINE; MEPROBAMATE; PSYCHOTROPIC AGENT; NEUROLEPTIC AGENT;

ALZHEIMER DISEASE; DISEASE COURSE; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG TREATMENT FAILURE; ERROR; EVIDENCE BASED MEDICINE; EXTERNAL BIAS; HUMAN; NONHUMAN; REVIEW; TREATMENT RESPONSE; DRUG DEVELOPMENT; MENTAL DISORDERS; PROCEDURES; PSYCHOLOGY; QUALITY OF LIFE; TREATMENT OUTCOME;

ALZHEIMER DISEASE; ANTIPSYCHOTIC AGENTS; DRUG DISCOVERY; HUMANS; MENTAL DISORDERS; PSYCHOTROPIC DRUGS; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84938282311     PISSN: 22150366     EISSN: 22150374     Source Type: Journal    
DOI: 10.1016/S2215-0366(15)00214-X     Document Type: Review

References (75)

1. Maxwell RA, Eckhardt SB Drug discovery 1990, 143-154. Humana Press, New York.
2. Whitehouse PJ, Price DL, Clark AW, Coyle JT, DeLong MR Alzheimer disease: evidence for selective loss of cholinergic neurons in the nucleus basalis. Ann Neurol 1981, 10:122-126.
3. Summers WK, Majovski LV, Marsh GM, Tachiki K, Kling A Oral tetrahydroaminoacridine in long-term treatment of senile dementia, Alzheimer type. N Engl J Med 1986, 315:1241-1245.
4. 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, 275:251-283.
5. Vishal S, Sourabh A, Harkirat S Alois Alzheimer (1864-1915) and the Alzheimer syndrome. J Med Biogr 2011, 19:32-33.
6. Braak H, Braak E Frequency of stages of Alzheimer-related lesions in different age categories. Neurobiol Aging 1997, 18:351-357.
7. Rodrigue KM, Kennedy KM, Devous MD, et al. β-Amyloid burden in healthy aging: regional distribution and cognitive consequences. Neurology 2012, 78:387-395.
8. Jack CR, Knopman DS, Jagust WJ, et al. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade. Lancet Neurol 2010, 9:119-128.
9. Fein JA, Sokolow S, Miller CA, et al. Co-localization of amyloid beta and tau pathology in Alzheimer's disease synaptosomes. Am J Pathol 2008, 172:1683-1692.
10. Crimins JL, Pooler A, Polydoro M, Luebke JI, Spires-Jones TL The intersection of amyloid β and tau in glutamatergic synaptic dysfunction and collapse in Alzheimer's disease. Ageing Res Rev 2013, 12:757-763.
11. Eckerström C, Olsson E, Klasson N, et al. Multimodal prediction of dementia with up to 10 years follow up: the Gothenburg MCI study. J Alzheimers Dis 2015, 44:205-214.
12. Landau SM, Frosch MP Tracking the earliest pathologic changes in Alzheimer disease. Neurology 2014, 82:1576-1577.
13. Becker RE, Greig NH, Giacobini E, Schneider LS, Ferrucci L A new roadmap for drug development for Alzheimer's disease. Nat Rev Drug Discov 2014, 13:156.
14. McDermott T Scientists can't get their minds around Alzheimer's (accessed April 14, 2015). http://articles.latimes.com/2007/dec/27/nation/la-na-alzheimers27dec27.
15. Vellas B Tarenflurbil for Alzheimer's disease: a "shot on goal" that missed. Lancet Neurol 2010, 9:235-237.
16. McGorry P, Keshavan M, Goldstone S, et al. Biomarkers and clinical staging in psychiatry. World Psychiatry 2014, 13:211-223.
17. Aisen PS, Vellas B, Hampel H Moving towards early clinical trials for amyloid-targeted therapy in Alzheimer's disease. Nat Rev Drug Discov 2013, 12:324.
18. Becker RE, Greig NH A new regulatory road-map for Alzheimer's disease drug development. Curr Alzheimer Res 2014, 11:215-220.
19. McFarlane WR Prevention of the first episode of psychosis. Psychiatr Clin North Am 2011, 34:95-107.
20. Cornblatt BA, Lencz T, Kane JM Treatment of the schizophrenia prodrome: is it presently ethical?. Schizophr Res 2001, 51:31-38.
21. Rapoport JL, Giedd JN, Gogtay N Neurodevelopmental model of schizophrenia: update 2012. Mol Psychiatry 2012, 17:1228-1238.
22. Ban TA Fifty years of chlorpromazine: a historical perspective. Neuropsychiatr Dis Treat 2007, 3:495-500.
23. Carlsson A, Lindqvist M Effect of chlorpromazine and haloperidol on formation of 3-methoxytyramine and normetanephrine on mouse brain. Acta Pharmacol Toxicol (Copenh) 1963, 20:140-144.
24. López-Muñoz F, Alamo C Monoaminergic neurotransmission: the history of the discovery of antidepressants from 1950s until today. Curr Pharm Des 2009, 15:1563-1586.
25. Nestler EJ, Hyman SE Animal models of neuropsychiatric disorders. Nat Neurosci 2010, 13:1161-1169.
26. Fuchs E, Flïugge G Experimental animal models for the simulation of depression and anxiety. Dialogues Clin Neurosci 2006, 8:323-333.
27. Shekhar A, McCann UD, Meaney MJ, et al. Summary of a National Institute of Mental Health workshop: developing animal models of anxiety disorders. Psychopharmacology (Berl) 2001, 157:327-339.
28. Hyman SE Psychiatric drug development: diagnosing a crisis. Cerebrum 2013, 2013:5.
29. Lane RM Antidepressant drug development: focus on triple reuptake inhibition. J Psychopharmacol 2014, published online Oct 14. 10.1177/0269881114553252.
30. Klein DF, Glick ID Industry withdrawal from psychiatric medication development. Rev Bras Psiquiatr 2014, 36:259-261.
31. Introducing IMI IMI, (accessed April 14, 2015). http://www.imi.europa.eu/content/mission.
32. Becker RE, Greig NH Neuropsychiatric clinical trials: lost in translation. Sci Transl Med 2010, 2:61rv6.
33. Wilcock GK, Black SE, Hendrix SB, Zavitz KH, Swabb EA, Laughlin MA Efficacy and safety of tarenflurbil in mild to moderate Alzheimer's disease: a randomised phase II trial. Lancet Neurol 2008, 7:483-493. and the Tarenflurbil Phase II Study investigators.
34. Selkoe DJ Resolving controversies on the path to Alzheimer's therapeutics. Nat Med 2011, 17:1060-1065.
35. Borchers AT, Hagie F, Keen CL, Gershwin ME The history and contemporary challenges of the US Food and Drug Administration. Clin Ther 2007, 29:1-16.
36. Janssen WF The story of the laws behind the labels. US Food and Drug Administration (accessed April 14, 2015). http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm.
37. Krishnaswamy S, Verdile G, Groth D, Kanyenda L, Martins RN The structure and function of Alzheimer's gamma secretase enzyme complex. Crit Rev Clin Lab Sci 2009, 46:282-301.
38. Biological insights from 108 schizophrenia-associated genetic loci. Nature 2014, 511:421-427. Schizophrenia Working Group of the Psychiatric Genomics Consortium.
39. Potter WZ, Mallinckrodt CH, Detke MJ Controlling placebo response in drug development: lessons learned from psychopharmacology. Pharmaceutical Med 2014, 28:53-65.
40. Rutherford BR, Pott E, Tandler JM, Wall MM, Roose SP, Lieberman JA Placebo response in antipsychotic clinical trials: a meta-analysis. JAMA Psychiatry 2014, 71:1409-1421.
41. Halford A Global survey of academic translational researchers: reproducibility, current practices, barriers to progress, and future directions (2014) (accessed March 23, 2015). http://go.sigmaaldrich.com/Translational-Survey.
42. Prinz F, Schlange T, Asadullah K Believe it or not: how much can we rely on published data on potential drug targets?. Nat Rev Drug Discov 2011, 10:712.
43. James JT A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf 2013, 9:122-128.
44. Cummings J Phase 2A trial of bexarotene in patients with Alzheimer's disease. The AlzForum (accessed April 14, 2015). http://www.alzforum.org/pap/annotation.asp?powID=147562.
45. Hippius H The history of clozapine. Psychopharmacology (Berl) 1989, 99(suppl):S3-S5.
46. Crilly J The history of clozapine and its emergence in the US market: a review and analysis. Hist Psychiatry 2007, 18:39-60.
47. Kane J, Honigfeld G, Singer J, Meltzer H Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry 1988, 45:789-796.
48. Alvir JM, Lieberman JA, Safferman AZ, Schwimmer JL, Schaaf JA Clozapine-induced agranulocytosis. Incidence and risk factors in the United States. N Engl J Med 1993, 329:162-167.
49. Seeman P Atypical antipsychotics: mechanism of action. Can J Psychiatry 2002, 47:27-38.
50. Newcomer JW Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 2005, 19(suppl 1):1-93.
51. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry 2006, 163:185-194.
52. Leucht S, Komossa K, Rummel-Kluge C, et al. A meta-analysis of head-to-head comparisons of second-generation antipsychotics in the treatment of schizophrenia. Am J Psychiatry 2009, 166:152-163.
53. Cutler AJ, Schwartz TL The pharmacology of MDD treatment: building a foundation with a focus on 5-HT. Medscape Education Psychiatry & Mental Health CME Released: 11/22/2013 (accessed April 14, 2015). http://www.medscape.org/viewarticle/814593.
54. Correll CU Vortioxetine: A new antidepressant choice in the United States. Medscape (accessed March 23, 2015). http://www.medscape.com/viewarticle/811959_3.
55. Appelbaum PS, Gold A Psychiatrists' relationships with industry: the principal-agent problem. Harv Rev Psychiatry 2010, 18:255-265.
56. Wimber M, Alink A, Charest I, Kriegeskorte N, Anderson MC Retrieval induces adaptive forgetting of competing memories via cortical pattern suppression. Nat Neurosci 2015, 18:582-589.
57. Lewis S Candidate for Governor: And how I got licked (1935) 1994, 109. University of California Press, Berkeley, CA.
58. Swartz MS, Stroup TS, McEvoy JP, et al. What CATIE found: results from the schizophrenia trial. Psychiatr Serv 2008, 59:500-506.
59. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 2006, 163:1905-1917.
60. Wisniewski SR, Rush AJ, Nierenberg AA, et al. Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. Am J Psychiatry 2009, 166:599-607.
61. Insel TR The NIMH Research Domain Criteria (RDoC) Project: precision medicine for psychiatry. Am J Psychiatry 2014, 171:395-397.
62. Insel T Director's Blog: A new approach to clinical trials (accessed April 14, 2015). http://www.nimh.nih.gov/about/director/2014/a-new-approach-to-clinical-trials.shtml.
63. Miller G Is pharma running out of brainy ideas?. Science 2010, 329:502-504.
64. Lyketsos CG, Carrillo MC, Ryan JM, et al. Neuropsychiatric symptoms in Alzheimer's disease. Alzheimers Dement 2011, 7:532-539.
65. Becker RE, Vicari S Management of Alzheimer's disease: community based care for patients and families. Home Health Care Consultant 1998, 5:11-17.
66. Kleinman A Rebalancing academic psychiatry: why it needs to happen-and soon. Br J Psychiatry 2012, 201:421-422.
67. Bracken P, Thomas P, Timimi S, et al. Psychiatry beyond the current paradigm. Br J Psychiatry 2012, 201:430-434.
68. Chang DK, Grimmond SM, Evans TRJ, Biankin AV Mining the genomes of exceptional responders. Nat Rev Cancer 2014, 14:291-292.
69. De Palma M, Hanahan D The biology of personalized cancer medicine: facing individual complexities underlying hallmark capabilities. Mol Oncol 2012, 6:111-127.
70. Zawia NH, Lahiri DK Epigenetics: a paradigm shift in understanding Alzheimer's disease. Curr Alzheimer Res 2012, 9:525-526.
71. Buckley PF Antipsychotic polypharmacy in schizophrenia: 'secret sauce or wild abandon?'. Polypharmacy in Psychiatry Practice 2013, Volume II:3-10. Springer, Netherlands. M.S. Ritsner (Ed.).
72. Repurposing drugs National Center for Advancing Translational Sciences, (accessed April 14, 2015). http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/rescue-repurpose.html.
73. Reason J Human Error 2001, Cambridge University Press, Cambridge.
74. Becker RE Remembering Sir William Osler 100 years after his death: what can we learn from his legacy?. Lancet 2014, 384:2260-2263.
75. Becker RE, Greig NH Why so few drugs for Alzheimer's disease? Are methods failing drugs?. Curr Alzheimer Res 2010, 7:642-651.