Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer's disease

Alzheimer's and Dementia: Translational Research and Clinical Interventions

Volumn 1, Issue 1, 2015, Pages 23-36

  Maher Edwards, Gareth ^a   Watson, Carolyn ^b   Ascher, John ^b   Barnett, Carly ^a   Boswell, Diane ^a   Davies, John ^a   Fernandez, Manuel ^c   Kurz, Alexander ^d   Zanetti, Orazio ^e   Safirstein, Beth ^f   Schronen, Juan Paul ^g   Zvartau Hind, Marina ^a   Gold, Michael ^b,h  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

^c BIOCRUCES BIZKAIA HEALTH RESEARCH INSTITUTE   (Spain)

^d TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^e IRCCS ISTITUTO CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI   (Italy)

^f MD Clinical   (United States)

^g Cape Heart Centre   (South Africa)

^h UCB PHARMA   (Belgium)

Author keywords

5 HT6 antagonist; ADAS Cog; Alzheimer's disease; CDR SB; CIBIC+; Donepezil

Indexed keywords

3 PHENYLSULFONYL 8 (1 PIPERAZINYL)QUINOLINE; DONEPEZIL; PLACEBO;

ADULT; AGED; ALZHEIMER DISEASE; AREA UNDER THE CURVE; ARTICLE; ASSESSMENT OF HUMANS; BACKACHE; BRONCHITIS; CEREBROVASCULAR ACCIDENT; CLINICAL DEMENTIA RATING; CLINICIAN INTERVIEW BASED IMPRESSION OF CHANGE PLUS CAREGIVER INPUT; CONCENTRATION AT STEADY-STATE; CONTROLLED STUDY; CONTUSION; CORNELL SCALE FOR DEPRESSION IN DEMENTIA; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DSM-IV; FEMALE; FOLLOW UP; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERTENSION; INFLUENZA; INTERACTIVE VOICE RESPONSE SYSTEM; MAJOR CLINICAL STUDY; MALE; MAXIMUM LIKELIHOOD METHOD; MINI MENTAL STATE EXAMINATION; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; STUDY; URINARY TRACT INFECTION; VOMITING;

EID: 84944038299     PISSN: None     EISSN: 23528737     Source Type: Journal    
DOI: 10.1016/j.trci.2015.04.001     Document Type: Article

References (29)

1. N. Upton, T.T. Chuang, A.J. Hunter, and D.J. Virley 5-HT6 receptor antagonists as novel cognitive enhancing agents for Alzheimer's disease Neurotherapeutics 5 2008 458 469
2. X. Codony, J.M. Vela, and M.J. Ramirez 5-HT(6) receptor and cognition Curr Opin Pharmacol 11 2011 94 100
3. G. Rosse, and H. Schaffhauser 5-HT6 receptor antagonists as potential therapeutics for cognitive impairment Curr Top Med Chem 10 2010 207 221
4. W.D. Hirst, T.O. Stean, T.C. Rogers, D. Sunter, P. Pugh, S.F. Moss, and et al. SB-399885 is a potent, selective 5-HT6 receptor antagonist with cognitive enhancing properties in aged rat water maze and novel object recognition models Eur J Pharmacol 553 2006 109 119
5. G. Maher-Edwards, R. Dixon, J. Hunter, M. Gold, G. Hopton, G. Jacobs, and et al. SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study Int J Geriatr Psychiatry 26 2011 536 544
6. G. Maher-Edwards, M. Zvartau-Hind, A.J. Hunter, M. Gold, G. Hopton, G. Jacobs, and et al. Double-blind, controlled phase II study of a 5-HT6 receptor antagonist, SB-742457, in Alzheimer's disease Curr Alzheimer Res 7 2010 374 385
7. L.A. Dawson, H.Q. Nguyen, and P. Li The 5-HT(6) receptor antagonist SB-271046 selectively enhances excitatory neurotransmission in the rat frontal cortex and hippocampus Neuropsychopharmacology 25 2001 662 668
8. L.P. Lacroix, L.A. Dawson, J.J. Hagan, and C.A. Heidbreder 5-HT6 receptor antagonist SB-271046 enhances extracellular levels of monoamines in the rat medial prefrontal cortex Synapse 51 2004 158 164
9. B. Marcos, T.T. Chuang, F.J. Gil-Bea, and M.J. Ramirez Effects of 5-HT6 receptor antagonism and cholinesterase inhibition in models of cognitive impairment in the rat Br J Pharmacol 155 2008 434 440
10. B. Marcos, F.J. Gil-Bea, W.D. Hirst, M. Garcia-Alloza, and M.J. Ramirez Lack of localization of 5-HT6 receptors on cholinergic neurons: implication of multiple neurotransmitter systems in 5-HT6 receptor-mediated acetylcholine release Eur J Neurosci 24 2006 1299 1306
11. C. Riemer, E. Borroni, B. Levet-Trafit, J.R. Martin, S. Poli, R.H. Porter, and et al. Influence of the 5-HT6 receptor on acetylcholine release in the cortex: pharmacological characterization of 4-(2-Bromo-6-pyrrolidin-1-ylpyridine-4-sulfonyl)phenylamine, a potent and selective 5-HT6 receptor antagonist J Med Chem 46 2003 1273 1276
12. National Institute for Health and Clinical Excellence Dementia: supporting people with dementia and their carers in health and social care (NICE clinical guideline 42) 2006 (modifed 2012). Available at: http://www.nice.org.uk/guidance/cg42 Accessed on August 2014
13. N.M. de Bruin, J. Prickaerts, A. van Loevezijn, J. Venhorst, L. de Groote, P. Houba, and et al. Two novel 5-HT6 receptor antagonists ameliorate scopolamine-induced memory deficits in the object recognition and object location tasks in Wistar rats Neurobiol Learn Mem 96 2011 392 402
14. American Psychiatric Association Diagnostic and statistical manual of mental disorders 4th ed. 1994 American Psychiatric Association Washington, DC
15. G. McKhann, D. Drachman, M. Folstein, R. Katzman, D. Drice, and E.M. Stadlan 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 34 1984 939 944
16. M.F. Folstein, S.E. Folstein, and P.R. McHugh "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician J Psychiatr Res 12 1975 189 198
17. W.G. Rosen, R.D. Terry, P.A. Fuld, R. Katzman, and A. Peck Pathological verification of ischemic score in differentiation of dementias Ann Neurol 7 1980 486 488
18. L.S. Schneider, J.T. Olin, R.S. Doody, C.M. Clark, J.C. Morris, B. Reisberg, and et al. Validity and reliability of the Alzheimer's Disease Cooperative Study - clinical global impression of change. The Alzheimer's Disease Cooperative Study Alzheimer Dis Assoc Disord 11 Suppl 2 1997 S22 S32
19. J.C. Morris The Clinical Dementia Rating (CDR): current version and scoring rules Neurology 43 1993 2412 2414
20. D. Galasko, D. Bennett, M. Sano, C. Ernesto, R. Thomas, M. Grundman, and et al. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study Alzheimer Dis Assoc Disord 11 Suppl 2 1997 S33 S39
21. C. Randolph Repeatable battery for the assessment of neuropsychological status 1st ed. 1998 The Psychologcal Corporation: Harcourt Brace and Company New York
22. G.S. Alexopoulos, R.C. Abrams, R.C. Young, and C.A. Shamoian Cornell Scale for Depression in Dementia Biol Psychiatry 23 1988 271 284
23. P. Lane Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches Pharm Stat 7 2008 93 106
24. R.W. Jones Dimebon disappointment Alzheimers Res Ther 2 2010 25
25. M. Panisset, S. Gauthier, H. Moessler, M. Windisch Cerebrolysin Study Group Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent J Neural Transm 109 2002 1089 1104
26. R.E. Becker, N.H. Greig, and E. Giacobini Why do so many drugs for Alzheimer's disease fail in development? Time for new methods and new practices? J Alzheimers Dis 15 2008 303 325
27. M. Gold Study design factors and patient demographics and their effect on the decline of placebo-treated subjects in randomized clinical trials in Alzheimer's disease J Clin Psychiatry 68 2007 430 438
28. M.C. Irizarry, D.J. Webb, C. Bains, S.J. Barrett, R.Y. Lai, J.P. Laroche, and et al. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease J Alzheimer Dis 14 2008 301 311
29. D. Wilkinson, K. Windfeld, and E. Colding-Jørgensen Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer's disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial Lancet Neurol 13 2014 1092 1099