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A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease


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.


Neurology, Volume: 73, No.: 24, Pages.: 2061-2070

Year of Publication



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). Patients received 6 infusions, 13 weeks apart, with final assessments at week 78. The prespecified primary efficacy analysis in the modified intent-to-treat population assumed linear decline and compared treatment differences within dose cohorts on the Alzheimer’s Disease Assessment Scale-Cognitive and Disability Assessment for Dementia. Exploratory analyses combined dose cohorts and did not assume a specific pattern of decline.; Results: No significant differences were found in the primary efficacy analysis. Exploratory analyses showed potential treatment differences (p < 0.05, unadjusted for multiple comparisons) on cognitive and functional endpoints in study "completers" and APOE epsilon4 noncarriers. Reversible vasogenic edema, detected on brain MRI in 12/124 (9.7%) bapineuzumab-treated patients, was more frequent in higher dose groups and APOE epsilon4 carriers. Six vasogenic edema patients were asymptomatic; 6 experienced transient symptoms.; Conclusions: Primary efficacy outcomes in this phase 2 trial were not significant. Potential treatment differences in the exploratory analyses support further investigation of bapineuzumab in phase 3 with special attention to APOE epsilon4 carrier status.; Classification Of Evidence: Due to varying doses and a lack of statistical precision, this Class II ascending dose trial provides insufficient evidence to support or refute a benefit of bapineuzumab.;

Bibtex Citation

@article{Salloway_2009, doi = {10.1212/wnl.0b013e3181c67808}, url = {}, year = 2009, month = {nov}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {73}, number = {24}, pages = {2061--2070}, author = {S. Salloway and R. Sperling and S. Gilman and N. C. Fox and K. Blennow and M. Raskind and M. Sabbagh and L. S. Honig and R. Doody and C. H. van Dyck and R. Mulnard and J. Barakos and K. M. Gregg and E. Liu and I. Lieberburg and D. Schenk and R. Black and M. Grundman}, title = {A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease}, journal = {Neurology} }


administration & dosage, adverse effects, aged, alzheimer disease, antibodies monoclonal, antibodies monoclonal humanized, apolipoprotein e4, bapineuzumab, biological markers, brain, brain edema, cerebrospinal fluid, chemically induced, cognition, diagnosis, drug effects, drug therapy, female, genetics, heterozygote, humans, magnetic resonance imaging, male, pathology, psychology, severity of illness index, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions