Long-term follow up of patients with mild-to-moderate Alzheimer's disease treated with bapineuzumab in a Phase III, open-label, extension study
Background: A 3-year extension of two Phase III parent studies of intravenous (IV) bapineuzumab in patients with mildto- moderate Alzheimer's disease dementia (apolipoprotein (APOE) σ4 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 σ4 carriers and 774 were noncarriers) patients were enrolled. Extension-onset adverse events occurred in >81% of the patients in each dose group. Fall, urinary tract infection, agitation, and ARIA-E occurred in ≥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.
Journal of Alzheimer's Disease
Digital Object Identifier (DOI)
Salloway, Stephen P.; Sperling, Reisa; Fox, Nick C.; Sabbagh, Marwan N.; Honig, Lawrence S.; Porsteinsson, Anton P.; Rofael, Hany; Ketter, Nzeera; Wang, Daniel; Liu, Enchi; Carr, Stephen; Black, Ronald S.; and Brashear, H. Robert, "Long-term follow up of patients with mild-to-moderate Alzheimer's disease treated with bapineuzumab in a Phase III, open-label, extension study" (2018). Neurology. 931.