. A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology. 2009 Dec 15;73(24):2061-70. PubMed.

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  1. This may be a naive question, but if amyloid deposition in the brain is a critical factor in AD-related behavioral sequelae, why is it so difficult to induce a behavioral modification of statistical relevance following Aβ vaccination, since reports show a strong amyloid plaque clearance effect?

    View all comments by Elliott Mufson
  2. Although the outcome maybe wasn’t as good as had been hoped for, the Phase 2 study on Bapineuzumab, a humanized anti-Aβ monoclonal antibody, provided novel perspectives to the field of immunotherapy against Alzheimer disease. The study enrolled 234 patients with mild to moderate disease, and these were randomly assigned to intravenous antibody infusion or placebo in four dose cohorts (0.15, 0.5, 1.0, or 2.0 mg/kg). After completing the protocol with six infusions, the patients were assessed after 1.5 years. Although no significant differences were found in the primary efficacy analyses, slight differences in cognition could be seen among ApoE ε4 non-carriers. Unfortunately, vasogenic edema occurred in 10 percent of the treated patients and was more frequent in ApoE ε4 carriers who received the higher doses. Ongoing large separate Phase 3 studies on ε4 carriers and ε4 non-carriers, respectively, will be crucial for treatment evaluation—and teach us more about which patients can gain from passive anti-Aβ immunotherapy.