Use of theragnostic markers to select drugs for phase II/III trials for Alzheimer disease

Alzheimer's Research and Therapy

Volumn 2, Issue 6, 2010, Pages

  Zetterberg, Henrik ^a   Mattsson, Niklas ^a   Blennow, Kaj ^a   Olsson, Bob ^a  

^a UNIVERSITY OF GOTHENBURG   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLOID; AMYLOID BETA PROTEIN; AMYLOID BETA PROTEIN[1-42]; AMYLOID PRECURSOR PROTEIN; BRYOSTATIN 1; GAMMA SECRETASE INHIBITOR; INTERLEUKIN 1BETA; INTERLEUKIN 6; MEMANTINE; NEUROFILAMENT PROTEIN; PROTEIN KINASE C; TUMOR NECROSIS FACTOR ALPHA; VARENICLINE;

ALZHEIMER DISEASE; CELL ACTIVATION; CELL ACTIVITY; CEREBROSPINAL FLUID; DISEASE COURSE; DRUG TARGETING; HUMAN; MEMORY CONSOLIDATION; MICROGLIA; NEUROTRANSMISSION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN PHOSPHORYLATION; REVIEW; SENSITIVITY AND SPECIFICITY;

EID: 78649721324     PISSN: None     EISSN: 17589193     Source Type: Journal    
DOI: 10.1186/alzrt56     Document Type: Review

References (50)

1. Alzheimer's disease. K Blennow MJ de Leon H Zetterberg, Lancet 2006 368 387 403 10.1016/S0140-6736(06)69113-7 16876668
2. Alzheimer's disease. HW Querfurth FM LaFerla, N Engl J Med 2010 362 329 344 10.1056/NEJMra0909142 20107219
3. Cerebrospinal fluid and plasma biomarkers in Alzheimer disease. K Blennow H Hampel M Weiner H Zetterberg, Nat Rev Neurol 2010 6 131 144 10.1038/nrneurol.2010.4 20157306
4. How can we recognize 'disease modification' effects? ER Siemers, J Nutr Health Aging 2009 13 341 343 10.1007/s12603-009-0036-7 19300873
5. Cerebrospinal fluid total tau as a marker of Alzheimer's disease intensity. K Samgard H Zetterberg K Blennow O Hansson L Minthon E Londos, Int J Geriatr Psychiatry 2010 25 403 410 10.1002/gps.2353 19650161
6. Rapid progression from mild cognitive impairment to Alzheimer's disease in subjects with elevated levels of tau in cerebrospinal fluid and the APOE epsilon4/epsilon4 genotype. ES Blom V Giedraitis H Zetterberg H Fukumoto K Blennow BT Hyman MC Irizarry LO Wahlund L Lannfelt M Ingelsson, Dement Geriatr Cogn Disord 2009 27 458 464 10.1159/000216841 19420940
7. Phosphorylated tau predicts rate of cognitive decline in MCI subjects: a comparative CSF study. K Buerger M Ewers N Andreasen R Zinkowski K Ishiguro E Vanmechelen SJ Teipel C Graz K Blennow H Hampel, Neurology 2005 65 1502 1503 10.1212/01.wnl.0000183284.92920.f2 16275849
8. CSF phosphorylated tau protein correlates with neocortical neurofibrillary pathology in Alzheimer's disease. K Buerger M Ewers T Pirttilä R Zinkowski I Alafuzoff SJ Teipel J DeBernardis D Kerkman C McCulloch H Soininen H Hampel, Brain 2006 129 3035 3041 10.1093/brain/awl269 17012293
9. Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. T Tapiola I Alafuzoff SK Herukka L Parkkinen P Hartikainen H Soininen T Pirttila, Arch Neurol 2009 66 382 389 10.1001/archneurol.2008.596 19273758
10. Inverse relation between in vivo amyloid imaging load and cerebrospinal fluid Abeta42 in humans. AM Fagan MA Mintun RH Mach SY Lee CS Dence AR Shah GN LaRossa ML Spinner WE Klunk CA Mathis ST DeKosky JC Morris DM Holtzman, Ann Neurol 2006 59 512 519 10.1002/ana.20730 16372280
11. PET imaging of amyloid deposition in patients with mild cognitive impairment. A Forsberg H Engler O Almkvist G Blomquist G Hagman A Wall A Ringheim B Langstrom A Nordberg, Neurobiol Aging 2008 29 1456 1465 10.1016/j.neurobiolaging.2007.03.029 17499392
12. CSF Abeta 42 levels correlate with amyloid-neuropathology in a population-based autopsy study. D Strozyk K Blennow LR White LJ Launer, Neurology 2003 60 652 656 12601108
13. Future screening for incipient Alzheimer's disease - the influence of prevalence on test performance. N Mattsson H Zetterberg, Eur Neurol 2009 62 200 203 10.1159/000228591 19602894
14. Beyond the neurotransmitter-focused approach in treating Alzheimer's disease: drugs targeting beta-amyloid and tau protein. F Panza V Solfrizzi V Frisardi BP Imbimbo C Capurso A D'Introno AM Colacicco D Seripa G Vendemiale A Capurso A Pilotto, Aging Clin Exp Res 2009 21 386 406 20154508
15. Total and phosphorylated tau protein as biological markers of Alzheimer's disease. H Hampel K Blennow LM Shaw YC Hoessler H Zetterberg JQ Trojanowski, Exp Gerontol 2010 45 30 40 10.1016/j.exger.2009.10.010 19853650
16. Distribution of tau proteins in the normal human central and peripheral nervous system. JQ Trojanowski T Schuck ML Schmidt VM Lee, J Histochem Cytochem 1989 37 209 215 2492045
17. The phosphorylation of tau: a critical stage in neurodevelopment and neurodegenerative processes. S Lovestone CH Reynolds, Neuroscience 1997 78 309 324 10.1016/S0306-4522(96)00577-5 9145789
18. Changing face of microglia. MB Graeber, Science 2010 330 783 788 10.1126/science.1190929 21051630
19. Microglial Cx3cr1 knockout prevents neuron loss in a mouse model of Alzheimer's disease. M Fuhrmann T Bittner CK Jung S Burgold RM Page G Mitteregger C Haass FM LaFerla H Kretzschmar J Herms, Nat Neurosci 2010 13 411 413 10.1038/nn.2511 20305648
20. Role of toll-like receptor signalling in Abeta uptake and clearance. K Tahara HD Kim JJ Jin JA Maxwell L Li K Fukuchi, Brain 2006 129 3006 3019 10.1093/brain/awl249 16984903
21. ClinicalTrials.gov homepage. http://clinicaltrials.gov
22. The uses of biomarkers in drug development. O Hurko, Ann N Y Acad Sci 2009 1180 1 10 10.1111/j.1749-6632.2009.04946.x 19906255
23. Are surrogate markers adequate to assess cardiovascular disease drugs? R Temple, JAMA 1999 282 790 795 10.1001/jama.282.8.790 10463719
24. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Biomarkers Definitions Working Group, Clin Pharmacol Ther 2001 69 89 95 10.1067/mcp.2001.113989 11240971
25. Role of biochemical Alzheimer's disease biomarkers as end points in clinical trials. E Siemers RB DeMattos PC May RA Dean, Biomark Med 2010 4 81 89 10.2217/bmm.09.85 20387304
26. Biomarkers and surrogate markers: an FDA perspective. R Katz, NeuroRx 2004 1 189 195 10.1602/neurorx.1.2.189 15717019
27. Reductions in beta-amyloid concentrations in vivo by the gammasecretase inhibitors BMS-289948 and BMS-299897. JJ Anderson G Holtz PP Baskin M Turner B Rowe B Wang MZ Kounnas BT Lamb D Barten K Felsenstein I McDonald K Srinivasan B Munoz SL Wagner, Biochem Pharmacol 2005 69 689 698 10.1016/j.bcp.2004.11.015 15670587
28. Studies of Abeta pharmacodynamics in the brain, cerebrospinal fluid, and plasma in young (plaque-free) Tg2576 mice using the gamma-secretase inhibitor N2-[(2S)- 2-(3,5-difluorophenyl)-2-hydroxyethanoyl]-N1-[(7S)-5-methyl-6-oxo-6,7- dihydro-5H-dibenzo[b,d]azepin-7-yl]-L-alaninamide (LY-411575). TA Lanz JD Hosley WJ Adams KM Merchant, J Pharmacol Exp Ther 2004 309 49 55 10.1124/jpet.103. 060715 14718585
29. First demonstration of cerebrospinal fluid and plasma A beta lowering with oral administration of a beta-site amyloid precursor protein-cleaving enzyme 1 inhibitor in nonhuman primates. S Sankaranarayanan MA Holahan D Colussi MC Crouthamel V Devanarayan J Ellis A Espeseth AT Gates SL Graham AR Gregro D Hazuda JH Hochman K Holloway L Jin J Kahana MT Lai J Lineberger G McGaughey KP Moore P Nantermet B Pietrak EA Price H Rajapakse S Stauffer MA Steinbeiser G Seabrook HG Selnick XP Shi MG Stanton J Swestock,, et al. J Pharmacol Exp Ther 2009 328 131 140 10.1124/jpet.108.143628 18854490
30. Nanoparticle-based detection in cerebral spinal fluid of a soluble pathogenic biomarker for Alzheimer's disease. DG Georganopoulou L Chang JM Nam CS Thaxton EJ Mufson WL Klein CA Mirkin, Proc Natl Acad Sci USA 2005 102 2273 2276 10.1073/pnas.0409336102 15695586
31. Update on amyloid-beta homeostasis markers for sporadic Alzheimer's disease. H Zetterberg, Scand J Clin Lab Invest 2009 69 18 21 10.1080/00365510802651841 19199126
32. High-molecular-weight {beta}-amyloid oligomers are elevated in cerebrospinal fluid of Alzheimer patients. H Fukumoto T Tokuda T Kasai N Ishigami H Hidaka M Kondo D Allsop M Nakagawa, FASEB J 2010 24 2716 2726 10.1096/fj.09-150359 20339023
33. 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. L Lannfelt K Blennow H Zetterberg S Batsman D Ames J Harrison CL Masters S Targum AI Bush R Murdoch J Wilson CW Ritchie PBT2-201-EURO study group, Lancet Neurol 2008 7 779 786 10.1016/S1474-4422(08)70167-4 18672400
34. Effect of phenserine treatment on brain functional activity and amyloid in Alzheimer's disease. A Kadir N Andreasen O Almkvist A Wall A Forsberg H Engler G Hagman M Larksater B Winblad H Zetterberg K Blennow B Langstrom A Nordberg, Ann Neurol 2008 63 621 631 10.1002/ana.21345 18300284
35. Clinical effects of Abeta immunization (AN1792) in patients with AD in an interrupted trial. S Gilman M Koller RS Black L Jenkins SG Griffith NC Fox L Eisner L Kirby MB Rovira F Forette Orgogozo JM; AN1792(QS-21)-201 Study Team, Neurology 2005 64 1553 1562 10.1212/01.WNL.0000159740.16984.3C 15883316
36. Phase 2 safety trial targeting amyloid beta production with a gamma-secretase inhibitor in Alzheimer disease. AS Fleisher R Raman ER Siemers L Becerra CM Clark RA Dean MR Farlow JE Galvin ER Peskind JF Quinn A Sherzai BB Sowell PS Aisen LJ Thal, Arch Neurol 2008 65 1031 1038 10.1001/archneur.65.8. 1031 18695053
37. A gamma-secretase inhibitor decreases amyloid-beta production in the central nervous system. RJ Bateman ER Siemers KG Mawuenyega G Wen KR Browning WC Sigurdson KE Yarasheski SW Friedrich RB Demattos PC May SM Paul DM Holtzman, Ann Neurol 2009 66 48 54 10.1002/ana.21623 19360898
38. A novel pathway for amyloid precursor protein processing. E Portelius E Price G Brinkmalm M Stiteler M Olsson R Persson A Westman-Brinkmalm H Zetterberg AJ Simon K Blennow, Neurobiol Aging 2009
39. A novel Abeta isoform pattern in CSF reflects gammasecretase inhibition in Alzheimer disease. E Portelius RA Dean MK Gustavsson U Andreasson H Zetterberg E Siemers K Blennow, Alzheimers Res Ther 2010 2 7 10.1186/alzrt30 20350302
40. Neurochemical aftermath of amateur boxing. H Zetterberg MA Hietala M Jonsson N Andreasen E Styrud I Karlsson A Edman C Popa A Rasulzada LO Wahlund PD Mehta L Rosengren K Blennow A Wallin, Arch Neurol 2006 63 1277 1280 10.1001/archneur.63.9.1277 16966505
41. Effects of memantine on cerebrospinal fluid biomarkers of neurofibrillary pathology. L Glodzik S De Santi KE Rich M Brys E Pirraglia R Mistur R Switalski L Mosconi M Sadowski H Zetterberg K Blennow MJ de Leon, J Alzheimers Dis 2009 18 509 513 19661628
42. Reduction of phosphorylated tau during memantine treatment of Alzheimer's disease. M Degerman Gunnarsson L Kilander H Basun L Lannfelt, Dement Geriatr Cogn Disord 2007 24 247 252 10.1159/000107099 17700020
43. Monocyte chemoattractant protein-1 (MCP-1): an overview. SL Deshmane S Kremlev S Amini BE Sawaya, J Interferon Cytokine Res 2009 29 313 326 10.1089/jir.2008.0027 19441883
44. Plasma chitotriosidase in health and pathology. R Barone S Sotgiu S Musumeci, Clin Lab 2007 53 321 333 17605408
45. Intrathecal chemokine synthesis in mild cognitive impairment and Alzheimer disease. D Galimberti N Schoonenboom P Scheltens C Fenoglio F Bouwman E Venturelli I Guidi MA Blankenstein N Bresolin E Scarpini, Arch Neurol 2006 63 538 543 10.1001/archneur.63.4.538 16606766
46. Increased intrathecal levels of the angiogenic factors VEGF and TGF-beta in Alzheimer's disease and vascular dementia. E Tarkowski R Issa M Sjogren A Wallin K Blennow A Tarkowski P Kumar, Neurobiol Aging 2002 23 237 243 10.1016/S0197-4580(01)00285-8 11804709
47. Increased cerebrospinal fluid levels of transforming growth factor-beta1 in Alzheimer's disease. H Zetterberg N Andreasen K Blennow, Neurosci Lett 2004 367 194 196 10.1016/j.neulet.2004.06.001 15331151
48. A meta-analysis of cytokines in Alzheimer's disease. W Swardfager K Lanctot L Rothenburg A Wong J Cappell N Herrmann, Biol Psychiatry 2010 68 930 941 10.1016/j.biopsych.2010.06.012 20692646
49. Non-steroidal anti-inflammatory drugs and Alzheimer's disease: the epidemiological evidence. CA Szekely PP Zandi, CNS Neurol Disord Drug Targets 2010 9 132 139 20205647
50. Tarenflurbil: mechanisms and myths. M Sano, Arch Neurol 2010 67 750 752 10.1001/archneurol.2010.94 20558395