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A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease
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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.
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“Frequency of ARIA events and in particular ARIA-E was significantly higher among APOE ε4 allele carriers compared to non-carriers, making the APOE ε4 allele a risk factor for vascular complications of anti-Aβ immunotherapy [5, 8, 14, 15].”
From APOE Genotype Differentially Modulates Effects of Anti-Aβ, Passive Immunization in APP Transgenic Mice (2017) · cites this paper as [15]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“Frequency of ARIA events and in particular ARIA-E was significantly higher among APOE ε4 allele carriers compared to non-carriers, making the APOE ε4 allele a risk factor for vascular complications of anti-Aβ immunotherapy [5, 8, 14, 15].”
From APOE Genotype Differentially Modulates Effects of Anti-Aβ, Passive Immunization in APP Transgenic Mice (2017) · cites this paper as [15]
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“The greater incidence of these abnormalities with increasing bapineuzumab dose and number of APOEε4 alleles is consistent with phase 2 findings.11,13”
From Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Alzheimer's Disease (2014) · cites this paper as [13]
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“Although clinical trials of the Aβ-directed mAb Bapinezumab showed no clear cognitive benefits in patients with mild to moderate AD [42], the results also indicated that APOE ε4 carrier status may limit the response to anti-Aβ passive immunization [43,44], as well as being associated with an increased rate of microbleeds and vasogenic edema [45].”
From Blocking the apoE/Aβ interaction ameliorates Aβ-related pathology in APOE ε2 and ε4 targeted replacement Alzheimer model mice (2014) · cites this paper as [44]
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“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 [183]
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“In fact, there have been hints of some beneficial effects (clinical and biochemical) linked to human anti-Aβ immunotherapies (74-79).”
From Correlation of Alzheimer Disease Neuropathologic Changes With Cognitive Status: A Review of the Literature (2012) · cites this paper as [76]
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Metadata
- Authors
- 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.
- Affiliations
- Brigham and Women's Hospital (US)
- From the Butler Hospital (S.S.), Providence, RI; Brigham & Women's Hospital (R.S.), Boston, MA; University of Michigan (S.G.), Ann Arbor; UCL (N.C.F.), Institute of Neurology, London, UK; University of Göteborg (K.B.), Sahlgrenska University Hospital, Mölndal, Sweden; VA Medical Center (M.R.), Seattle, WA; Cleo Roberts Center for Clinical Research/Sun Health Research Institute (M.S.), Sun City, AZ; Columbia University (L.S.H.), New York, NY; Baylor College of Medicine (R.D.), Houston, TX; Yale...
- Venue
- Neurology
- Published
- 2009-12-15
- Volume
- 73
- Issue
- 24
- Pages
- 2061-2070
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC2790221
- OpenAlex
- W2086572083
- Cited by
- 753
- References
- 40
- Citations by year
- 2026: 18 · 2025: 20 · 2024: 25 · 2023: 21 · 2022: 34 · 2021: 21 · 2020: 30 · 2019: 30 · 2018: 26 · 2017: 30 · 2016: 45 · 2015: 52 · 2014: 71 · 2013: 78 · 2012: 91
- FWCI
- 55.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Pfizer
- National Institute for Health and Care Research (NF-SI-0508-10123)
- National Institutes of Health (5r03ag023916-02, 5r01ag007370-30, 1r41ns056856-01a2, 5u01ag024904-10)
- U.S. Public Health Service (UO1AGO24904)
- National Institute on Alcohol Abuse and Alcoholism (RL1AA017536)
- National Institute on Aging (U01-AG-024904, R01AG030457, R01AG14763, AG 08671, 1-R01-AG030457-01A1, P01AG007232, R01AG026114, U01AG016976, R01-AG007370, R43AG033474, U01AG010483, U01-AG 16976, 1-UO1-AG024904, 1 R03 AG023916-01A1, P01AG030004, P50AG008702, R01AG027435, R01AG017761, P01AG07232, P50AG008671, P30AG019610, P30 P3-AG 019610, P50AG005136, P50AG005134, U01AG032438, P50 AG08671, 5-U01-AG10483, AG06036-13, P50AG08702)
- National Heart, Lung, and Blood Institute (R01HL091099)
- National Institute of Mental Health (1 R01 MH58620-01A2, P50MH068789, R01MH058620)
- National Institute of Diabetes and Digestive and Kidney Diseases (IR21DK062098)
- National Institute of Neurological Disorders and Stroke (P01 NS 15655, P01NS015655, R01NS042859, T32NS007224)
- National Center for Research Resources (U54RR024350-01, P20RR020626)
- 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
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Keywords
- bapineuzumab, Alzheimer's disease, anti-amyloid beta monoclonal antibody, amyloid-beta, vasogenic edema, APOE ε4 carriers, cognitive decline, functional decline, dose escalation, treatment efficacy, drug safety
- MeSH terms
- Aged, Alzheimer Disease, Antibodies, Monoclonal, Brain, Brain Edema, Cognition, Dose-Response Relationship, Drug, Female, Heterozygote, Humans, Magnetic Resonance Imaging, Male, Severity of Illness Index, Biomarkers, Treatment Outcome, Apolipoprotein E4, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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