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

Zetterberg, Henrik

doi:10.1001/archneurol.2012.90

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

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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In phase 2 clinical studies, bapineuzumab reduced amyloid on PIB-PET more than placebo in patients with mild-to-moderate Alzheimer's disease.
“In phase 2 clinical studies involving patients with mild-to-moderate Alzheimer’s disease, patients who received bapineuzumab, as compared with those who received placebo, had a greater reduction in amyloid on positron-emission tomographic amyloid imaging with the use of Pittsburgh compound B (PIB-PET) and reduced cerebrospinal fluid phosphorylated tau (phospho-tau), suggesting target engagement”
From Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Alzheimer's Disease (2014) · cites this paper as [9]
In phase 2 clinical studies, bapineuzumab reduced cerebrospinal fluid phospho-tau in patients with mild-to-moderate Alzheimer's disease.
“In phase 2 clinical studies involving patients with mild-to-moderate Alzheimer’s disease, patients who received bapineuzumab, as compared with those who received placebo, had a greater reduction in amyloid on positron-emission tomographic amyloid imaging with the use of Pittsburgh compound B (PIB-PET) and reduced cerebrospinal fluid phosphorylated tau (phospho-tau), suggesting target engagement”
From Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Alzheimer's Disease (2014) · cites this paper as [9]
In phase II trials, the anti-Aβ antibody bapineuzumab reduced CSF phospho-tau levels in patients with AD.
“in phase II trials, the anti-Aβ antibody bapineuzumab reduced CSF phospho-tau levels in patients with AD182,183”
From Tau-targeting therapies for Alzheimer disease (2018) · cites this paper as [182]

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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: 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, 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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