To the top

Page Manager: Webmaster
Last update: 9/11/2012 3:13 PM

Tell a friend about this page
Print version

A phase 2 multiple ascend… - University of Gothenburg, Sweden Till startsida
To content Read more about how we use cookies on

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

Journal article
Authors S Salloway
R Sperling
S Gilman
N C Fox
Kaj Blennow
M Raskind
M Sabbagh
L S Honig
R Doody
C H van Dyck
R Mulnard
J Barakos
K M Gregg
E Liu
I Lieberburg
D Schenk
R Black
M Grundman
Published in Neurology
Volume 73
Issue 24
Pages 2061-70
ISSN 1526-632X
Publication year 2009
Published at Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
Pages 2061-70
Language en
Keywords Aged, Alzheimer Disease, diagnosis, drug therapy, genetics, psychology, Antibodies, Monoclonal, administration & dosage, adverse effects, Apolipoprotein E4, genetics, Biological Markers, cerebrospinal fluid, Brain, pathology, Brain Edema, chemically induced, diagnosis, Cognition, drug effects, Dose-Response Relationship, Drug, Female, Heterozygote, Humans, Magnetic Resonance Imaging, Male, Severity of Illness Index, Treatment Outcome
Subject categories Psychiatry


BACKGROUND: Bapineuzumab, a humanized anti-amyloid-beta (Abeta) monoclonal antibody for the potential treatment of Alzheimer disease (AD), was evaluated in a multiple ascending dose, safety, and efficacy study in mild to moderate AD. METHODS: The study enrolled 234 patients, randomly assigned to IV bapineuzumab or placebo in 4 dose cohorts (0.15, 0.5, 1.0, or 2.0 mg/kg). Patients received 6 infusions, 13 weeks apart, with final assessments at week 78. The prespecified primary efficacy analysis in the modified intent-to-treat population assumed linear decline and compared treatment differences within dose cohorts on the Alzheimer's Disease Assessment Scale-Cognitive and Disability Assessment for Dementia. Exploratory analyses combined dose cohorts and did not assume a specific pattern of decline. RESULTS: No significant differences were found in the primary efficacy analysis. Exploratory analyses showed potential treatment differences (p < 0.05, unadjusted for multiple comparisons) on cognitive and functional endpoints in study "completers" and APOE epsilon4 noncarriers. Reversible vasogenic edema, detected on brain MRI in 12/124 (9.7%) bapineuzumab-treated patients, was more frequent in higher dose groups and APOE epsilon4 carriers. Six vasogenic edema patients were asymptomatic; 6 experienced transient symptoms. CONCLUSIONS: Primary efficacy outcomes in this phase 2 trial were not significant. Potential treatment differences in the exploratory analyses support further investigation of bapineuzumab in phase 3 with special attention to APOE epsilon4 carrier status. Classification of evidence: Due to varying doses and a lack of statistical precision, this Class II ascending dose trial provides insufficient evidence to support or refute a benefit of bapineuzumab.

Page Manager: Webmaster|Last update: 9/11/2012

The University of Gothenburg uses cookies to provide you with the best possible user experience. By continuing on this website, you approve of our use of cookies.  What are cookies?