Vandenberghe, R;
Rinne, JO;
Boada, M;
Katayama, S;
Scheltens, P;
Vellas, B;
Tuchman, M;
... Black, RS; + view all
(2016)
Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials.
Alzheimer's Research & Therapy
, 8
, Article 18. 10.1186/s13195-016-0189-7.
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Abstract
Background: Our objective was to evaluate the efficacy (clinical and biomarker) and safety of intravenous bapineuzumab in patients with mild to moderate Alzheimer’s disease (AD). Methods: Two of four phase 3, multicenter, randomized, double-blind, placebo-controlled, 18-month trials were conducted globally: one in apolipoprotein E ε4 carriers and another in noncarriers. Patients received bapineuzumab 0.5 mg/kg (both trials) or 1.0 mg/kg (noncarrier trial) or placebo every 13 weeks. Coprimary endpoints were change from baseline to week 78 on the 11-item Alzheimer’s Disease Assessment Scale–Cognitive subscale and the Disability Assessment for Dementia. Results: A total of 683 and 329 patients completed the current carrier and noncarrier trials, respectively, which were terminated prematurely owing to lack of efficacy in the two other phase 3 trials of bapineuzumab in AD. The current trials showed no significant difference between bapineuzumab and placebo for the coprimary endpoints and no effect of bapineuzumab on amyloid load or cerebrospinal fluid phosphorylated tau. (Both measures were stable over time in the placebo group.) Amyloid-related imaging abnormalities with edema or effusion were confirmed as the most notable adverse event. Conclusions: These phase 3 global trials confirmed lack of efficacy of bapineuzumab at tested doses on clinical endpoints in patients with mild to moderate AD. Some differences in the biomarker results were seen compared with the other phase 3 bapineuzumab trials. No unexpected adverse events were observed.
| Type: | Article |
|---|---|
| Title: | Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13195-016-0189-7 |
| Publisher version: | https://doi.org/10.1186/s13195-016-0189-7 |
| Language: | English |
| Additional information: | Copyright © 2016 Vandenberghe et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| Keywords: | Alzheimer’s disease, Bapineuzumab, Immunotherapy, Amyloid β, Clinical trial, ARIA-E, Vasogenic edema |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Med Phys and Biomedical Eng |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10064547 |
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