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A single ascending dose study of bapineuzumab in patients with Alzheimer disease


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


Alzheimer Disease And Associated Disorders, Volume: 24, No.: 2, Pages.: 198-203

Year of Publication



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 and 1.5-mg/kg cohorts; 10 active, 4 placebo for 5.0-mg/kg cohort). Three patients in the highest dose cohort (5.0 mg/kg) developed magnetic resonance imaging abnormalities consistent with vasogenic edema, predominantly high signal abnormalities on fluid-attenuated inversion recovery sequences, all of which resolved over time. Plasma amyloid beta was elevated from baseline, peaking approximately 24 hours after infusion. PK analysis demonstrated a half-life of 21 to 26 days, supporting a 13-week dosing interval for bapineuzumab. This small, single-dose study demonstrated the safety profile and PK characteristics of bapineuzumab and was used to design later safety and efficacy trials.;

Bibtex Citation

@article{Black_2010, doi = {10.1097/wad.0b013e3181c53b00}, url = {}, year = 2010, month = {apr}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {24}, number = {2}, pages = {198--203}, author = {Ronald S. Black and Reisa A. Sperling and Beth Safirstein and Ruth N. Motter and Allan Pallay and Alice Nichols and Michael Grundman}, title = {A Single Ascending Dose Study of Bapineuzumab in Patients With Alzheimer Disease}, journal = {Alzheimer Disease {&} Associated Disorders} }


administration & dosage, adverse effects, aged, aged, 80 and over, alzheimer disease, antibodies monoclonal, antibodies monoclonal humanized, bapineuzumab, drug, drug therapy, female, humans, immunology, magnetic resonance imaging, male, middle aged, neuropsychological tests, nootropic agents, pathology, pharmacokinetics, safety

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions