A Single Ascending Dose Study of Bapineuzumab in Patients With Alzheimer Disease : Alzheimer Disease & Associated Disorders

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

Black, Ronald S. MD*; Sperling, Reisa A. MD; Safirstein, Beth MD; Motter, Ruth N. MPH§; Pallay, Allan MS*; Nichols, Alice PhD*; Grundman, Michael MD, MPH§

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Alzheimer Disease & Associated Disorders 24(2):p 198-203, April 2010. | DOI: 10.1097/WAD.0b013e3181c53b00


The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB–001), a humanized monoclonal antibody to amyloid β, 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 β 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.

© 2010 Lippincott Williams & Wilkins, Inc.

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