Cited by 235Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchNeuroinflammation and Neurodegeneration Mechanisms

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Effect of Immunotherapy With Bapineuzumab on Cerebrospinal Fluid Biomarker Levels in Patients With Mild to Moderate Alzheimer Disease

Zetterberg, Henrik·2012·Archives of Neurology

DOI 10.1001/archneurol.2012.90

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Abstract

BACKGROUND: Given the slow and variable clinical course of Alzheimer disease, very large and extended clinical trials are needed to identify a beneficial clinical effect of disease-modifying treatments. Therefore, biomarkers are essential to prove that an anti-β-amyloid (Aβ) drug candidate affects both Aβ metabolism and plaque load as well as downstream pathogenic mechanisms. OBJECTIVE: To evaluate the effect of the anti-Aβ monoclonal antibody bapineuzumab on cerebrospinal fluid (CSF) biomarkers reflecting Aβ homeostasis, neuronal degeneration, and tau-related pathology in patients with Alzheimer disease. DESIGN: Two phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trials of 12-month duration. SETTING: Academic centers in the United States (Study 201) and England and Finland (Study 202). PATIENTS: Forty-six patients with mild to moderate Alzheimer disease. INTERVENTIONS: Patients received either placebo (n = 19) or bapineuzumab (n = 27) in 3 or 4 ascending dose groups. MAIN OUTCOME MEASURES: Changes between end of study and baseline in the exploratory CSF biomarkers Aβ1-42, AβX-42, AβX-40; total tau (T-tau); and phosphorylated tau (P-tau). RESULTS: Within the bapineuzumab group, a decrease at end of study compared with baseline was found both for CSF T-tau (-72.3 pg/mL) and P-tau (-9.9 pg/mL). When comparing the treatment and placebo groups, this difference was statistically significant for P-tau (P = .03), while a similar trend for a decrease was found for T-tau (P = .09). No clear-cut differences were observed for CSF Aβ. CONCLUSIONS: To our knowledge, this study is the first to show that passive Aβ immunotherapy with bapineuzumab results in decreases in CSF T-tau and P-tau, which may indicate downstream effects on the degenerative process. Cerebrospinal fluid biomarkers may be useful to monitor the effects of novel disease-modifying anti-Aβ drugs in clinical trials. TRIAL REGISTRATIONS clinicaltrials.gov Identifier: NCT00112073, EudraCT Identifier: 2004-004120-12, and isrctn.org Identifier: ISRCTN17517446.

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Authors: Zetterberg, H.
Affiliations: University of Gothenburg (SE)
Corresponding author: Zetterberg, Henrik
ORCID: Zetterberg, Henrik
Venue: Archives of Neurology
Publisher: American Medical Association (AMA)
Published: 2012-08-01
Volume: 69
Issue: 8
Pages: 1002
ISSN: 0003-9942 (ISSN-L)
DOI: 10.1001/archneurol.2012.90
OpenAlex: W2004535959
Cited by: 234
References: 29
Citations by year: 2026: 3 · 2025: 3 · 2024: 5 · 2023: 9 · 2022: 8 · 2021: 12 · 2020: 10 · 2019: 4 · 2018: 16 · 2017: 12 · 2016: 24 · 2015: 25 · 2014: 44 · 2013: 39 · 2012: 18
FWCI: 27.02
Type: journal article
Language: en
Open access: closed
Locations: Archives of Neurology (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › 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, cerebrospinal fluid biomarkers, anti-amyloid monoclonal antibodies, passive immunotherapy, amyloid-beta, tau phosphorylation, total tau, amyloid-beta 42, Aβ40, disease-modifying therapy, neurodegeneration, amyloid plaques
MeSH terms: Aged, Alzheimer Disease, Double-Blind Method, England, Female, Finland, Humans, Immunotherapy, Male, Middle Aged, Peptide Fragments, United States, Cohort Studies, Biomarkers, Amyloid beta-Peptides, tau Proteins, Treatment Outcome, Antibodies, Monoclonal, Humanized

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Effect of Immunotherapy With Bapineuzumab on Cerebrospinal Fluid Biomarker Levels in Patients With Mild to Moderate Alzheimer Disease

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