Blennow, Kaj, Zetterberg, Henrik, Rinne, Juha O., Salloway, Stephen, Wei, Jenny, Black, Ronald, Grundman, Michael, Liu, Enchi

Background: Given the slow and variable clinical course of Alzheimer disease, very large and extended clinical trials are needed to identify a beneficial clinical effect of disease-modifying treatments. Therefore, biomarkers are essential to prove that an anti-β-amyloid (Aβ) drug candidate affects both Aβ metabolism and plaque load as well as downstream pathogenic mechanisms.; Objective: To […]

Farlow, Martin, Arnold, Steven E., van Dyck, Christopher H., Aisen, Paul S, Snider, B. Joy, Porsteinsson, Anton P., Friedrich, Stuart, Dean, Robert A., Gonzales, Celedon, Sethuraman, Gopalan, Demattos, Ronald B., Mohs, Richard, Paul, Steven M., Siemers, Eric R.

Objectives: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of 12 weekly infusions of solanezumab, an anti-β-amyloid (Aβ) antibody, in patients with mild-to-moderate Alzheimer’s disease. Cognitive measures were also obtained.; Methods: In this phase 2, randomized, double-blind, placebo-controlled clinical trial, 52 patients with Alzheimer’s disease received placebo or antibody (100 mg every 4 weeks, 100 […]

Salloway, Stephen, Sperling, Reisa, Fox, Nick C., Blennow, Kaj, Klunk, William, Raskind, Murray, Sabbagh, Marwan, Honig, Lawrence S., Porsteinsson, Anton P., Ferris, Steven, Reichert, Marcel, Ketter, Nzeera, Nejadnik, Bijan, Guenzler, Volkmar, Miloslavsky, Maja, Wang, Daniel, Lu, Yuan, Lull, Julia, Tudor, Iulia Cristina, Liu, Enchi, Grundman, Michael, Yuen, Eric, Black, Ronald, Brashear, H. Robert

Background: Bapineuzumab, a humanized anti-amyloid-beta monoclonal antibody, is in clinical development for the treatment of Alzheimer’s disease.; Methods: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials involving patients with mild-to-moderate Alzheimer’s disease–one involving 1121 carriers of the apolipoprotein E (APOE) ε4 allele and the other involving 1331 noncarriers. Bapineuzumab or placebo, with doses varying […]