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A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non-Carriers (301) or Carriers (302)


This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, out-patient study to assess whether an investigational drug, bapineuzumab is safe, well tolerated and effective.  Male and female participants 50 - <89 years of age with mild to moderate Alzheimer's disease who do not carry the Apolipoprotein E4 allele will be recruited. Participants will be randomized to receive either bapineuzumab at one of three dose levels, 0.5mg, 1.0mg, 2.0mg or placebo by infusion every 13 weeks for a total of six infusions over 18 months. Cognitive testing, vital signs (blood pressure, height, weight, pulse rate, body temperature and breathing rate), medical history, physical and neurological examinations, echocardiograms, laboratory samples will be taken and MRI's will also be performed. There are 200-250 study sites participating in the U.S. and Canada. Of the 1250 participants who will be enrolled, 750 participants will receive active study drug and 500 will received placebo.  Additionally, there are four optional sub-studies; volumetric brain MRI sub-study, brain PET sub-study, cerebrospinal fluid (CSF) sub-study and PK/PD/ECG Intensive Sampling Sub-Study. Approximately 300 subjects in the placebo group and 150 subjects in each of the bapineuzumab treatment groups at a subset of sites will participate in the Volumetric MRI sub-study. The purpose of the Volumetric MRI sub-study is to assess changes in brain size over time. Approximately 125 participants will take part in the PET sub-study for detection of abnormal protein deposits and activity in the brain. Approximately 100 subjects in the placebo group and 50 subjects in each of the three bapineuzumab dosing groups will participate in the CSF (cerebrospinal fluid) sub-study. The purpose of this sub-study is to measure proteins in spinal CSF that are known to be altered in subjects with Alzheimer’s disease (e.g. tau, phosphorylated tau, and beta-amyloid protein). In addition, levels of study drug (bapineuzumab) present in your CSF and levels of antibodies to the study drug (anti-bapineuzumab) will be measured.  The PK/PD/ECG sub-study is to gain additional information about blood levels and related parameters of bapineuzumab treatment that would not be obtainable from tests performed as part of the main study. A total of forty subjects will enroll into this pharmacokinetic sub-study.


Last Updated: 08-19-2016
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