Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: A multicenter, randomized, double-blind, placebo-controlled, dose-escalation study

International Journal of Clinical Pharmacology and Therapeutics

Volumn 51, Issue 12, 2013, Pages 911-923

  Miyoshi, Izuru ^a   Fujimoto, Yoko ^a   Yamada, Masahito ^b   Abe, Sadahiro ^a   Zhao, Qinying ^a   Cronenberger, Carol ^a   Togo, Kanae ^a   Ishibashi, Taro ^a   Bednar, Martin M ^a   Kupiec, James W ^a   Binneman, Brendon ^a  

^a PFIZER INC   (United States)

^b KANAZAWA UNIVERSITY GRADUATE SCHOOL OF MEDICAL SCIENCE   (Japan)

Author keywords

Alzheimer's disease; Clinical pharmacology; Japanese subjects; PF 04360365; Safety

Indexed keywords

AMYLOID BETA PROTEIN; DRUG ANTIBODY; PLACEBO; PONEZUMAB;

ADULT; AGED; ALLERGIC REACTION; ALZHEIMER DISEASE; AREA UNDER THE CURVE; ARTICLE; BRAIN ATROPHY; BRAIN EDEMA; BRAIN HEMORRHAGE; CLINICAL ARTICLE; CONTACT DERMATITIS; CONTROLLED STUDY; DISTRIBUTION VOLUME; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CEREBROSPINAL FLUID LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ENCEPHALITIS; FEMALE; HEADACHE; HEART MUSCLE ISCHEMIA; HERPES ZOSTER; HUMAN; HYPERLIPIDEMIA; IMMUNOGENICITY; JAPANESE; MALE; MAXIMUM PLASMA CONCENTRATION; MINI MENTAL STATE EXAMINATION; MULTICENTER STUDY; NECK PAIN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIALOADENITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; WEIGHT REDUCTION; YOUNG ADULT;

AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; ANTIBODIES, MONOCLONAL, HUMANIZED; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED;

EID: 84891340165     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201816     Document Type: Article

References (32)

1. Ikejima C, Hisanaga A, Yamada T et al. Trends in the prevalence of dementia in Japan: Preliminary report. Presented at the Alzheimer's Association International Conference on Alzheimer's Disease Annual Meeting, July 16-21, 2011, Paris, France.
2. Rodda J, Morgan S, Walker Z. Are cholinesterase inhibitors effective in the management of the behavioral and psychological symptoms of dementia in Alzheimer's disease? A systematic review of randomized, placebo-controlled trials of donepezil, rivastigmine and galantamine. Int Psychogeriatr. 2009; 21: 813-824. CrossRef PubMed
3. Courtney C, Farrell D, Gray R, Hills R, Lynch L, Sellwood E, Edwards S, Hardyman W, Raftery J, Crome P, Lendon C, Shaw H, Bentham P; AD2000 Collaborative Group. Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial. Lancet. 2004; 363: 2105-2115. CrossRef PubMed
4. Hardy JA, Higgins GA. Alzheimer's disease: the amyloid cascade hypothesis. Science. 1992; 256: 184-185. CrossRef PubMed
5. DeMattos RB, Bales KR, Cummins DJ, Dodart JC, Paul SM, Holtzman DM. Peripheral anti-A beta antibody alters CNS and plasma A beta clearance and decreases brain A beta burden in a mouse model of Alzheimer's disease. Proc Natl Acad Sci USA. 2001; 98: 8850-8855. CrossRef PubMed
6. Gelinas DS, DaSilva K, Fenili D, St George-Hyslop P, McLaurin J. Immunotherapy for Alzheimer's disease. Proc Natl Acad Sci USA. 2004; 101 (Suppl 2): 14657-14662. CrossRef PubMed
7. Wilcock DM, Alamed J, Gottschall PE, Grimm J, Rosenthal A, Pons J, Ronan V, Symmonds K, Gordon MN, Morgan D. Deglycosylated anti-amyloid-β antibodies eliminate cognitive deficits and reduce parenchymal amyloid with minimal vascular consequences in aged amyloid precursor protein transgenic mice. J Neurosci. 2006; 26: 5340-5346. CrossRef PubMed
8. Orgogozo JM, Gilman S, Dartigues JF, Laurent B, Puel M, Kirby LC, Jouanny P, Dubois B, Eisner L, Flitman S, Michel BF, Boada M, Frank A, Hock C. Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization. Neurology. 2003; 61: 46-54. CrossRef PubMed
9. Ferrer I, Boada Rovira M, Sánchez Guerra ML, Rey MJ, Costa-Jussá F. Neuropathology and pathogenesis of encephalitis following amyloid-beta immunization in Alzheimer's disease. Brain Pathol. 2004; 14: 11-20. CrossRef PubMed
10. Pul R, Dodel R, Stangel M. Antibody-based therapy in Alzheimer's disease. Expert Opin Biol Ther. 2011; 11: 343-357. CrossRef PubMed
11. Black RS, Sperling RA, Safirstein B, Motter RN, Pallay A, Nichols A, Grundman M. A single ascending dose study of bapineuzumab in patients with Alzheimer disease. Alzheimer Dis Assoc Disord. 2010; 24: 198-203. CrossRef PubMed
12. Salloway S, Sperling R, Gilman S, Fox NC, Blennow K, Raskind M, Sabbagh M, Honig LS, Doody R, van Dyck CH, Mulnard R, Barakos J, Gregg KM, Liu E, Lieberburg I, Schenk D, Black R, Grundman M; Bapineuzumab 201 Clinical Trial Investigators. A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology. 2009; 73: 2061-2070. CrossRef PubMed
13. Siemers ER, Friedrich S, Dean RA, Gonzales CR, Farlow MR, Paul SM, Demattos RB. 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: 67-73. CrossRef PubMed
14. Bednar MM. Anti-amyloid antibody drugs in clinical testing for Alzheimer's disease. IDrugs. 2009; 12: 566-575. PubMed
15. Armour KL, Atherton A, Williamson LM, Clark MR. The contrasting IgG-binding interactions of human and herpes simplex virus Fc receptors. Biochem Soc Trans. 2002; 30: 495-500. CrossRef PubMed
16. Armour KL, van de Winkel JG, Williamson LM, Clark MR. Differential binding to human FcgammaRIIa and FcgammaRIIb receptors by human IgG wildtype and mutant antibodies. Mol Immunol. 2003; 40: 585-593. CrossRef PubMed
17. La Porte SL, Bollini SS, Lanz TA et al. Structural basis of C-terminal β-amyloid peptide binding by the antibody ponezumab for the treatment of Alzheimer's disease. J Mol Biol. 2012; 421: 525-536. PubMed
18. Landen JW, Zhao Q, Cohen S, Borrie M, Woodward M, Billing CB Jr, Bales K, Alvey C, McCush F, Yang J, Kupiec JW, Bednar MM. Safety and pharmacology of a single intravenous dose of ponezumab (PF-04360365) in subjects with mild-to-moderate Alzheimer's disease: A phase I, randomized, placebo-controlled, double-blind, dose-escalation study. Clin Neuropharmacol. 2013; 36: 14-23. CrossRef PubMed
19. Burstein AH, Zhao Q, Ross J, Styren S, Landen JW, Ma WW, McCush F, Alvey C, Kupiec JW, Bednar MM. Safety and pharmacology of ponezumab (PF-04360365) following a single 10-minute intravenous infusion in subjects with mild-to-moderate Alzheimer's disease. Clin Neuropharmacol. 2013; 36: 8-13. CrossRef PubMed
20. Folstein MF, Folstein SE, McHugh PR. "Minimental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975; 12: 189-198. CrossRef PubMed
21. 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. CrossRef PubMed
22. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IVTR). American Psychiatric Association, Arlington, VA; 2000.
23. Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS; March 31, 2003 (http://ctep.cancer.gov).
24. Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983; 19: 448-450. PubMed
25. Fredrickson J, Maruff P, Woodward M, Moore L, Fredrickson A, Sach J, Darby D. Evaluation of the usability of a brief computerized cognitive screening test in older people for epidemiological studies. Neuroepidemiology. 2010; 34: 65-75. CrossRef PubMed
26. Zhao Q, Landen J, Burstein AH, McCush F, Alvey C, Billing CB et al. Pharmacokinetics of ponezumab (PF-04360365) following a single-dose intravenous infusion in patients with mild to moderate Alzheimer's disease. Presented at the Alzheimer's Association International Conference on Alzheimer's Disease, July 10-15, 2010, Honolulu, Hawaii, USA (Abstract O3-07-05).
27. Seubert P, Barbour R, Khan K, Motter R, Tang P, Kholodenko D, Kling K, Schenk D, Johnson-Wood K, Schroeter S, Gill D, Jacobsen JS, Pangalos M, Basi G, Games D. Antibody capture of soluble Abeta does not reduce cortical Abeta amyloidosis in the PDAPP mouse. Neurodegener Dis. 2008; 5: 65-71. CrossRef PubMed
28. 42 deposition in a transgenic mouse model of Alzheimer disease. Proc Natl Acad Sci USA. 1997; 94: 1550-1555. CrossRef PubMed
29. Wilcock DM, Rojiani A, Rosenthal A, Subbarao S, Freeman MJ, Gordon MN, Morgan D. Passive immunotherapy against Aβ in aged APP-transgenic mice reverses cognitive deficits and depletes parenchymal amyloid deposits in spite of increased vascular amyloid and microhemorrhage. J Neuroinflammation. 2004; 1: 1-24. CrossRef PubMed
30. Freeman GB, Brown TP, Wallace K, Bales K. 6-month chronic study with ponezumab (PF-04360365) Chinese hamster ovary (CHO)-derived murine surrogate in aged Tg2576 mice. Presented at the Alzheimer's Association International Conference on Alzheimer's Disease Annual Meeting, July 16-21, 2011, Paris, France.
31. Goos JD, Kester MI, Barkhof F, Klein M, Blankenstein MA, Scheltens P, van der Flier WM. Patients with Alzheimer disease with multiple microbleeds: relation with cerebrospinal fluid biomarkers and cognition. Stroke. 2009; 40: 3455-3460. CrossRef PubMed
32. Goos JD, Henneman WJ, Sluimer JD, Vrenken H, Sluimer IC, Barkhof F, Blankenstein MA, Scheltens PH, van der Flier WM. Incidence of cerebral microbleeds: a longitudinal study in a memory clinic population. Neurology. 2010; 74: 1954-1960. CrossRef PubMed