A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease
Open accessAbstract
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.
“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]
The Safety section reports a higher rate of vasogenic edema in bapineuzumab-treated APOE ε4 carriers (13.5%; 10/74) than noncarriers (4.3%; 2/47). It does not report a statistical significance test for that comparison or establish the claimed difference for ARIA events more broadly. Page numbers are unavailable in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAPOE ε4 allele is a risk factor for vascular complications of anti-Aβ immunotherapy.
“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]
The Safety section reports vasogenic edema in 13.5% of bapineuzumab-treated APOE ε4 carriers versus 4.3% of noncarriers, supporting an association with this vascular complication. The paper does not establish that the difference was statistically significant or that the finding extends to anti-Aβ immunotherapies generally; it reports vasogenic edema rather than ARIA events broadly. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAPOE ε4 carrier status may limit the response to anti-Aβ passive immunization.
“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]
The greater incidence of ARIA-E with increasing bapineuzumab dose and number of APOE ε4 alleles is consistent with phase 2 findings.
“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]
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 [183]
There have been hints of some beneficial effects (clinical and biochemical) linked to human anti-Aβ immunotherapies.
“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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- 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
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › 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
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