@article{discovery10052380,
          number = {3},
         journal = {Journal of Alzheimer's Disease},
            year = {2018},
          volume = {64},
           title = {Long-Term Follow Up of Patients with Mild-to-Moderate Alzheimer's Disease Treated with Bapineuzumab in a Phase III, Open-Label, Extension Study},
            note = {This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.},
           pages = {689--707},
        keywords = {Alzheimer's disease, amyloid-related imaging abnormality with edema/effusions, bapineuzumab, long-term safety},
        abstract = {BACKGROUND: A 3-year extension of two Phase III parent studies of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease dementia (apolipoprotein (APOE) ?4 carriers and noncarriers) is summarized. OBJECTIVES: The primary and secondary objectives were to evaluate the long-term safety, tolerability, and maintenance of efficacy of bapineuzumab. METHODS: A multicenter study in patients who had participated in double-blind placebo-controlled parent studies. Patients enrolled in the extension study were assigned to receive IV infusions of bapineuzumab (0.5 or 1.0 mg/kg) every 13 weeks until termination but were blinded to whether they had received bapineuzumab or placebo in the parent studies. RESULTS: A total of 1,462 (688 were APOE?4 carriers and 774 were noncarriers) patients were enrolled. Extension-onset adverse events occurred in {\ensuremath{>}}81\% of the patients in each dose group. Fall, urinary tract infection, agitation, and ARIA-E occurred in {$\ge$}10\% of participants. The incidence proportion of ARIA-E was higher among carriers and noncarriers who received bapineuzumab for the first time in the extension study (11.8\% and 5.4\%, respectively) versus those who were previously exposed in the parent studies (5.1\% and 1.3\%, respectively). After 6 to 12 months exposure to bapineuzumab IV in the extension study, similar deterioration of cognition and function occurred with no significant differences between the dose groups. CONCLUSIONS: Infusion of bapineuzumab 0.5 or 1.0 mg/kg every 13 weeks for up to 3 years was generally well tolerated, with a safety and tolerability profile similar to that in previous studies.},
             url = {http://doi.org/10.3233/JAD-171157},
            issn = {1875-8908},
          author = {Salloway, SP and Sperling, R and Fox, NC and Sabbagh, MN and Honig, LS and Porsteinsson, AP and Rofael, H and Ketter, N and Wang, D and Liu, E and Carr, S and Black, RS and Brashear, HR}
}