A single ascending dose study of bapineuzumab in patients with Alzheimer disease.

Abstract	The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, were evaluated in patients with mild-to-moderate Alzheimer disease in a phase 1, randomized, third-party unblinded, placebo-controlled, single ascending dose trial. Thirty patients received bapineuzumab infusion of 0.5, 1.5, or 5 mg/kg or placebo (6 active, 2 placebo for 0.5 and 1.5-mg/kg cohorts; 10 active, 4 placebo for 5.0-mg/kg cohort). Three patients in the highest dose cohort (5.0 mg/kg) developed magnetic resonance imaging abnormalities consistent with vasogenic edema, predominantly high signal abnormalities on fluid-attenuated inversion recovery sequences, all of which resolved over time. Plasma amyloid beta was elevated from baseline, peaking approximately 24 hours after infusion. PK analysis demonstrated a half-life of 21 to 26 days, supporting a 13-week dosing interval for bapineuzumab. This small, single-dose study demonstrated the safety profile and PK characteristics of bapineuzumab and was used to design later safety and efficacy trials.
Authors	Ronald S Black, Reisa A Sperling, Beth Safirstein, Ruth N Motter, Allan Pallay, Alice Nichols, Michael Grundman
Journal	Alzheimer disease and associated disorders (Alzheimer Dis Assoc Disord) 2010 Apr-Jun Vol. 24 Issue 2 Pg. 198-203 ISSN: 1546-4156 [Electronic] United States
PMID	20505438 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Amyloid beta-Peptides Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Nootropic Agents bapineuzumab
Topics	Aged Aged, 80 and over Alzheimer Disease (drug therapy, pathology) Amyloid beta-Peptides (immunology) Antibodies, Monoclonal (administration & dosage, adverse effects, pharmacokinetics) Antibodies, Monoclonal, Humanized Dose-Response Relationship, Drug Female Humans Magnetic Resonance Imaging Male Middle Aged Neuropsychological Tests Nootropic Agents (administration & dosage, adverse effects)

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