A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease

Neurology

Volumn 73, Issue 24, 2009, Pages 2061-2070

  Salloway, S ^a   Sperling, R ^b   Gilman, S ^c   Fox, N C ^d   Blennow, K ^e   Raskind, M ^f   Sabbagh, M ^g   Honig, L S ^h   Doody, R ⁱ   Van Dyck, C H ^j   Mulnard, R ^k   Barakos, J ^l   Gregg, K M ^m   Liu, E ^m   Lieberburg, I ^m   Schenk, D ^m   Black, R ⁿ   Grundman, M ^m  

^a BROWN UNIVERSITY   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF MICHIGAN   (United States)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^f VETERANS AFFAIRS MEDICAL CENTER   (United States)

^g SUN HEALTH RESEARCH INSTITUTE   (United States)

^h Och Spine at New York Presbyterian Hospitals   (United States)

ⁱ BAYLOR COLLEGE OF MEDICINE   (United States)

^j YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l CALIFORNIA PACIFIC MEDICAL CENTER   (United States)

^m ELAN PHARMACEUTICALS   (United States)

ⁿ PFIZER INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN E; BAPINEUZUMAB; CHOLINESTERASE INHIBITOR; MEMANTINE; PLACEBO;

ADULT; AGED; ALZHEIMER DISEASE; ARTICLE; BACKACHE; CATARACT; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; EDEMA; FEMALE; GAIT DISORDER; HUMAN; HYPERTENSION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MINI MENTAL STATE EXAMINATION; MULTICENTER STUDY; MUSCLE SPASM; NUCLEAR MAGNETIC RESONANCE IMAGING; PARANOIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SIDE EFFECT; SKIN INJURY; SYNCOPE; VASOGENIC EDEMA; VOMITING; WEIGHT REDUCTION;

EID: 73349091534     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e3181c67808     Document Type: Article

References (34)

1. Selkoe DJ, Schenk D. Alzheimer's disease: molecular understanding predicts amyloid-based therapeutics. Annu Rev Pharmacol Toxicol 2003;43:545-584.
2. Schroeter S, Khan K, Barbour R, et al. Immunotherapy reduces vascular amyloid-beta in PDAPP mice. J Neurosci 2008;28:6787-6793.
3. Bard F, Cannon C, Barbour R, et al. Peripherally administered antibodies against amyloid beta-peptide enter the central nervous system and reduce pathology in a mouse model of Alzheimer disease. Nat Med 2000;6:916-919.
4. Buttini M, Masliah E, Barbour R, et al. Beta-amyloid im-munotherapy prevents synaptic degeneration in a mouse model of Alzheimer's disease. J Neurosci 2005;25:9096-9101. (Pubitemid 41500817)
5. Shankar GM, Li S, Mehta TH, et al. Amyloid-beta protein dimers isolated directly from Alzheimer's brains impair synaptic plasticity and memory. Nat Med 2008;14:837-842.
6. Bayer AJ, Bullock R, Jones RW, et al. Evaluation of the safety and immunogenicity of synthetic Abeta42 (AN1792) in patients with AD. Neurology 2005;64:94-101.
7. Gilman S, Koller M, Black RSK, et al. Clinical effects of Abeta immunization (AN1792) in patients with AD in an interrupted trial. Neurology 2005;64:1553-1562.
8. Orgogozo JM, Gilman S, Dartigues JF, et al. Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization. Neurology 2003;61:46-54.
9. Pride M, Seubert P, Grundman M, Hagen M, Eldridge J, Black RS. Progress in the active immunotherapeutic ap-proach to Alzheimer's disease: clinical investigations into AN1792-associated meningoencephalitis. Neurodegener Dis 2008;5:194-196.
10. McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. 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: 939-944.
11. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-198.
12. Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol 1980;7:486-488.
13. Hamilton M. A rating scale for depression. J Neurol Neu-rosurg Psychiatry 1960;23:56-62.
14. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-1364.
15. Mohs RC, Knopman D, Petersen RC, et al. Development of cognitive instruments for use in clinical trials of antide-mentia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope: The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11 suppl 2:S13-S21.
16. Gauthier S, Gelinas I, Gauthier L. Functional disability in Alzheimer's disease. Int Psychogeriatr 1997;9 suppl 1:163-165.
17. Harrison J, Minassian SL, Jenkins L, Black RS, Koller M, Grundman M. A neuropsychological test battery for use in Alzheimer disease clinical trials. Arch Neurol 2007;64: 1323-1329.
18. Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology 1993;43:2412-2414.
19. Blennow K, Wallin A, Ågren H, Spenger C, Siegfried J, Vanmechelen E. Tau protein in cerebrospinal fluid: a biochemical diagnostic marker for axonal degeneration in Alzheimer's disease? Mol Chem Neuropathol 1995;26: 231-245.
20. Vanmechelen E, Vanderstichele H, Davidsson P, et al. Quantification of tau phosphorylated at threonine 181 in human cerebrospinal fluid: a sandwich ELISA with a synthetic phosphopeptide for standardization. Neurosci Lett 2000;285:49-52.
21. Andreasen N, Hesse C, Davidsson P, et al. Cerebrospinal fluid /3-amyloid (1-42) in Alzheimer disease: differences between early-and late-onset Alzheimer disease and stability during the course of disease. Arch Neurol 1999;56:673-680.
22. Fox NC, Cousens S, Scahill R, Harvey RJ, Rossor MN. Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects. Arch Neurol 2000;57:339-344.
23. Chalmers K, Wilcock GK, Love S. APOE e4 influences the pathological phenotype of Alzheimer's disease by favouring cerebrovascular over parenchymal accumulation of A/3 protein. Neuropathol Appl Neurobiol 2003;29:231-238.
24. Kinnecom C, Lev MH, Wendell L, et al. Course of cerebral amyloid angiopathy-related inflammation. Neurology 2007;68:1411-1416.
25. Oh U, Gupta R, Krakauer JW, Khandji AG, Chin SS, Elkind MS. Reversible leukoencephalopathy associated with cerebral amyloid angiopathy. Neurology 2004;62: 494-497.
26. Casey SO, Sampaio RC, Michel E, Truwit CL. Posterior reversible encephalopathy syndrome: utility of fluid-attenuated inversion recovery MR imaging in the detection of cortical and subcortical lesions. AJNR Am J Neuroradiol 2000;21:1199-1206.
27. Lamy C, Oppenheim C, Meder JF, Mas JL. Neuroimaging in posterior reversible encephalopathy syndrome. J Neuroimaging 2004;14:89-96.
28. Boche D, Zotova E, Weller RO, et al. Consequence of Abeta immunization on the vasculature of human Alzheimer's disease brain. Brain 2008;131:3299-3310.
29. 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 randomized phase II trial. Lancet Neurol 2008;7:483-493.
30. Pirttila T, Wilcock G, Truyen L, Damaraju CV. Long-term efficacy and safety of galantamine in patients with mild-to-moderate Alzheimer's disease: multicenter trial. Eur J Neurol 2004;11:734-741.
31. Neumann PJ, Araki SS, Areculs A, et al. Measuring Alzheimer's disease progression with transition probabilities: estimates from CERAD. Neurol 2001;57:957-964.
32. Blennow K. CSF biomarkers for Alzheimer's disease: use in early diagnosis and evaluation of drug treatment. Expert Rev Mol Diagn 2005;5:661-672.
33. Oddo S, Billings L, Kesslak JP, Cribbs DH, LaFerla FM. Abeta immunotherapy leads to clearance of early, but not late, hyperphosphorylated tau aggregates via the protea-some. Neuron 2004;43:321-332.
34. Nicoll JAR, Wilkinson D, Holmes C, Steart P, Markham H, Weller RO. Neuropathology of human Alzheimer disease after immunization with amyloid-beta peptide: a case report. Nat Med 2003;9:448-452.