Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials

Alzheimer's Research and Therapy

Volumn 8, Issue 1, 2016, Pages

  Vandenberghe, Rik ^a   Rinne, Juha O ^b   Boada, Mercè ^c   Katayama, Sadao ^d   Scheltens, Philip ^e   Vellas, Bruno ^f   Tuchman, Michael ^g   Gass, Achim ^h   Fiebach, Jochen B ⁱ   Hill, Derek ^j   Lobello, Kasia ^k   Li, David ^k   McRae, Tom ^k   Lucas, Prisca ^k   Evans, Iona ^l   Booth, Kevin ^k   Luscan, Gerald ^k   Wyman, Bradley T ^k   Hua, Lisa ^k   Yang, Lingfeng ^k   Brashear, H Robert ^m   Black, Ronald S ^k   more..

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b TURKU UNIVERSITY HOSPITAL   (Finland)

^c Gran Via de Carles III   (Spain)

^d HIROSHIMA UNIVERSITY   (Japan)

^e VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^f TOULOUSE UNIVERSITY HOSPITAL   (France)

^g Palm Beach Neurological Group   (United States)

^h UNIVERSITY OF HEIDELBERG   (Germany)

ⁱ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^j IXICO PLC   (United Kingdom)

^k PFIZER INC   (United States)

^l PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^m JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

more..

Author keywords

Alzheimer's disease; Amyloid ; ARIA E; Bapineuzumab; Clinical trial; Immunotherapy; Vasogenic edema

Indexed keywords

AMYLOID; APOLIPOPROTEIN E4; BAPINEUZUMAB; PLACEBO; TAU PROTEIN; AMYLOID BETA PROTEIN; BIOLOGICAL MARKER; MAPT PROTEIN, HUMAN; MONOCLONAL ANTIBODY;

11 ITEM ALZHEIMER DISEASE ASSESSMENT SCALE COGNITIVE SUBSCALE; ALZHEIMER DISEASE; ANXIETY; ARTICLE; BRAIN HEMORRHAGE; CEREBRAL MICROHEMORRHAGE; CEREBROSPINAL FLUID; CONTROLLED STUDY; CONVULSION; DEEP VEIN THROMBOSIS; DISABILITY ASSESSMENT FOR DEMENTIA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EDEMA; EFFUSION; FEMALE; HEADACHE; HUMAN; HYPERSENSITIVITY; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROLOGIC EXAMINATION; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROTEIN PHOSPHORYLATION; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SEIZURE; SIDE EFFECT; TREATMENT DURATION; AGED; BRAIN; CLINICAL TRIAL; DIAGNOSTIC IMAGING; GENETICS; METABOLISM; NEUROPSYCHOLOGICAL TEST; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

AGED; ALZHEIMER DISEASE; AMYLOID BETA-PEPTIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; APOLIPOPROTEIN E4; BIOMARKERS; BRAIN; FEMALE; HUMANS; MALE; NEUROPSYCHOLOGICAL TESTS; POSITRON-EMISSION TOMOGRAPHY; SEVERITY OF ILLNESS INDEX; TAU PROTEINS; TREATMENT OUTCOME;

EID: 85007565787     PISSN: None     EISSN: 17589193     Source Type: Journal    
DOI: 10.1186/s13195-016-0189-7     Document Type: Article

References (12)

1. Lemere CA. Immunotherapy for Alzheimer's disease: hoops and hurdles. Mol Neurodegener. 2013;8:36.
2. Tayeb HO, Murray ED, Price BH, Tarazi FI. Bapineuzumab and solanezumab for Alzheimer's disease: is the 'amyloid cascade hypothesis' still alive? Expert Opin Biol Ther. 2013;13:1075-84.
3. Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, et al. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014;370:322-33.
4. Moreth J, Mavoungou C, Schindowski K. Passive anti-amyloid immunotherapy in Alzheimer's disease: what are the most promising targets? Immun Ageing. 2013;10:18.
5. Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, et al. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012;69: 1002-10.
6. Rinne JO, Brooks DJ, Rossor MN, Fox NC, Bullock R, Klunk WE, et al. 11C-PiB PET assessment of change in fibrillar amyloid-β load in patients with Alzheimer's disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study. Lancet Neurol. 2010;9:363-72.
7. Salloway S, Sperling R, Gilman S, Fox NC, Blennow K, Raskind M, et al. A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology. 2009;73:2061-70.
8. Blennow K, Hampel H, Zetterberg H. Biomarkers in amyloid-β immunotherapy trials in Alzheimer's disease. Neuropsychopharmacology. 2014;39:189-201.
9. Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, et al. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014;370:311-21.
10. Panza F, Solfrizzi V, Imbimbo BP, Giannini M, Santamato A, Seripa D, et al. Efficacy and safety studies of gantenerumab in patients with Alzheimer's disease. Expert Rev Neurother. 2014;14:973-86.
11. Liu E, Schmidt ME, Margolin R, Sperling R, Koeppe R, Mason NS, et al. Bapineuzumab 301 and 302 Clinical Trial Investigators. Amyloid-β 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015;85:692-700.
12. Sperling RA, Jack CR Jr, Black SE, Frosch MP, Greenberg SM, Hyman BT, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer's Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7:367-85.