Cited by 304Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchNeuroinflammation and Neurodegeneration Mechanisms

Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials

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Vandenberghe, Rik, Rinne, Juha O., Boada, Mercè, Katayama, Sadao, Scheltens, Philip, Vellas, Bruno, Tuchman, Michael, Gass, Achim +15 more·2016·Alzheimer's Research & Therapy

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. Trial registration: Noncarriers (3000) ClinicalTrials.gov identifier NCT00667810; registered 24 Apr 2008. Carriers (3001) ClinicalTrials.gov identifier NCT00676143; registered 2 May 2008.

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  • Administration of lecanemab manifested significant 27% slower progress in cognitive decline based on the primary endpoint CDR-SB and secondary endpoints.

    “The administration of this antibody manifested significant (27%) slower progress in cognitive decline in the patients based on the primary end points, the change from baseline at 19 months in the score on the CDR-SB”
  • Third-generation human immunoglobulin monoclonal antibodies aducanumab, donanemab, and lecanemab, directed against insoluble, modified, N-terminal truncated amyloid-beta and targeting plaque clearance, seem to benefit mild cognitive impairment or mild Alzheimer's disease dementia patients.

    “The third generation of human immunoglobulin monoclonal antibody (hmAB; aducanumab, donanemab, and lecanemab) directed against insoluble, modified, N-terminal truncated form of Aβ, targeting Aβ plaque clearance, seems to benefit MCI or AD with mild dementia patients [34, 37].”
  • In phase III trials, bapineuzumab had no effect on tau pathology.

    “these results did not extend to phase III trials, in which bapineuzumab had no effect on tau pathology184”

    From Tau-targeting therapies for Alzheimer disease (2018) · cites this paper as [184]

  • Recent failures of anti-amyloid agents in phase 3 clinical trials in patients with early-stage, mild, or mild-to-moderate stage Alzheimer disease were semagacestat, bapineuzumab, solanezumab, and the BACE inhibitors lanabecestat, verubecestat, and atabecestat.

    “Some of the recent failures of anti-amyloid agents in phase 3 clinical trials in patients with early-stage, mild, or mild-to-moderate stage AD were semagacestat,29 bapineuzumab,30 solanezumab31 and in similar trials of β-secretase inhibitors (BACE) lanabecestat,32 verubecestat,33 and atabecestat.34”

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Authors
Vandenberghe, R., Rinne, J. O., Boada, M., Katayama, S., Scheltens, P., Vellas, B., Tuchman, M., Gass, A., Fiebach, J. B., Hill, D., Lobello, K., Li, D., McRae, T., Lucas, P., Evans, I., Booth, K., Luscan, G., Wyman, B. T., Hua, L., Yang, L., Brashear, H. R., Black, R. S., & for the Bapineuzumab 3000 and 3001 Clinical Study Investigators
Affiliations
  • KU Leuven (BE)
  • University of Turku (FI)
  • Hiroshima University (JP)
  • Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
  • Centre Hospitalier Universitaire de Toulouse (FR)
  • Palm Beach Neurological Center (US)
  • University Medical Centre Mannheim (DE)
  • Center for Stroke Research Berlin (DE)
  • Pfizer (United States) (US)
  • Pfizer (France) (FR)
  • Pfizer (United Kingdom) (GB)
  • Janssen Alzheimer Immunotherapy Research & Development (United States) (US)
Corresponding author
Vandenberghe, Rik
Venue
Alzheimer's Research & Therapy
Published
2016-05-12
Volume
8
Issue
1
Pages
18-18
ISSN
1758-9193 (ISSN-L)
OpenAlex
W2385703614
Cited by
304
References
12
Citations by year
2026: 15 · 2025: 25 · 2024: 36 · 2023: 37 · 2022: 26 · 2021: 35 · 2020: 36 · 2019: 28 · 2018: 44 · 2017: 21 · 2016: 1
FWCI
25.22
Type
journal article
Language
en
Open access
Locations
  • Alzheimer s Research & Therapy (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
  • Pure Amsterdam UMC (acceptedVersion, other-oa)
  • Lirias (KU Leuven) (submittedVersion, other-oa)
  • UCL Discovery (University College London) (submittedVersion)
  • Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
  • Pfizer Inc.
  • Janssen Research and Development
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
Keywords
bapineuzumab, Alzheimer's disease, anti-amyloid therapy, amyloid-related imaging abnormalities, amyloid load, phosphorylated tau, cognitive decline, disability, drug safety, treatment efficacy
MeSH terms
Aged, Alzheimer Disease, Brain, Female, Humans, Male, Neuropsychological Tests, Severity of Illness Index, Biomarkers, Amyloid beta-Peptides, tau Proteins, Treatment Outcome, Positron-Emission Tomography, Apolipoprotein E4, Antibodies, Monoclonal, Humanized

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