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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
Links dx.doi.org/10.1212/WNL.0b013e3181c6...
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

Abstract

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.

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