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A Single Ascending Dose Study of Bapineuzumab in Patients With... » Isaúde
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Alzheimer Disease and Associated Disorders
2010-04-01 00:00:00

A Single Ascending Dose Study of Bapineuzumab in Patients With Alzheimer Disease

Descrição: 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. (C) 2010 Lippincott Williams & Wilkins, Inc.

Seção: Original Articles
Volume: 0
Autor: Black, Ronald S.; Sperling, Reisa A.; Safirstein, Beth; Motter, Ruth N.; Pallay, Allan; Nichols, Alice; Grundman, Michael


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