Uenaka, Kazunori, Nakano, Masako, Willis, Brian A., Friedrich, Stuart, Ferguson-Sells, Lisa, Dean, Robert A., Ieiri, Ichiro, Siemers, Eric R.

Objectives: Solanezumab is a humanized anti-amyloid β monoclonal antibody being developed as a passive immunization treatment to slow the progression of Alzheimer disease (AD). Pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after a single dose of solanezumab were compared between Japanese and white patients with AD.; Methods: Japanese and white patients with mild to moderate AD […]

Burstein, Aaron H, Zhao, Qinying, Ross, Joel, Styren, Scot, Landen, Jaren W., Ma, Wendy W., McCush, Fred, Alvey, Christine, Kupiec, James W., Bednar, Martin M.

Objective: Ponezumab (PF-04360365) is a humanized anti-amyloid beta (Aβ) monoclonal antibody designed for treatment of Alzheimer disease (AD). A single 2-hour intravenous infusion of 0.1 to 10 mg/kg was previously shown to be safe and well tolerated in subjects with mild to moderate AD, with measurable effects on plasma and cerebrospinal fluid Aβ. This phase […]

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 […]

Rinne, Juha O., Brooks, David J., Rossor, Martin N., Fox, Nick C., Bullock, Roger, Klunk, William E., Mathis, Chester A., Blennow, Kaj, Barakos, Jerome, Okello, Aren A., Rodriguez Martinez de Liano, Sofia, Liu, Enchi, Koller, Martin, Gregg, Keith M., Schenk, Dale, Black, Ronald, Grundman, Michael

Background: Carbon-11-labelled Pittsburgh compound B ((11)C-PiB) PET is a marker of cortical fibrillar amyloid-beta load in vivo. We used (11)C-PiB PET to investigate whether bapineuzumab, a humanised anti-amyloid-beta monoclonal antibody, would reduce cortical fibrillar amyloid-beta load in patients with Alzheimer’s disease.; Methods: Patients with mild-to-moderate Alzheimer’s disease were randomly assigned to receive intravenous bapineuzumab or […]

Siemers, Eric R., Friedrich, Stuart, Dean, Robert A., Gonzales, Celedon R., Farlow, Martin R., Paul, Steven M., Demattos, Ronald B.

Objectives: Active and passive immunization strategies have been suggested as possible options for the treatment of Alzheimer disease (AD). LY2062430 (solanezumab) is a humanized monoclonal antibody being studied as a putative disease-modifying treatment of AD.; Methods: Patients with mild to moderate AD were screened and selected for inclusion. Initial screening was performed for 54 subjects, […]

Black, Ronald S., Sperling, Reisa A., Safirstein, Beth, Motter, Ruth N., Pallay, Allan, Nichols, Alice, Grundman, Michael

The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, 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 […]

Salloway, S., Sperling, R., Gilman, S., Fox, N. C., Blennow, K., Raskind, M., Sabbagh, M., Honig, L. S., Doody, R., van Dyck, C. H., Mulnard, R., Barakos, J., Gregg, K. M., Liu, E., Lieberburg, I., Schenk, D., Black, R., Grundman, M.

Background: Bapineuzumab, a humanized anti-amyloid-beta (Abeta) monoclonal antibody for the potential treatment of Alzheimer disease (AD), was evaluated in a multiple ascending dose, safety, and efficacy study in mild to moderate AD.; Methods: The study enrolled 234 patients, randomly assigned to IV bapineuzumab or placebo in 4 dose cohorts (0.15, 0.5, 1.0, or 2.0 mg/kg). […]

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 […]