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A Single Ascending Dose Study of Bapineuzumab in Patients With Alzheimer Disease
Open accessAbstract
The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, were evaluated in patients with mild-to-moderate Alzheimer disease in a phase 1, randomized, third-party unblinded, placebo-controlled, single ascending dose trial. Thirty patients received bapineuzumab infusion of 0.5, 1.5, or 5 mg/kg or placebo (6 active, 2 placebo for 0.5 and 1.5-mg/kg cohorts; 10 active, 4 placebo for 5.0-mg/kg cohort). Three patients in the highest dose cohort (5.0 mg/kg) developed magnetic resonance imaging abnormalities consistent with vasogenic edema, predominantly high signal abnormalities on fluid-attenuated inversion recovery sequences, all of which resolved over time. Plasma amyloid beta was elevated from baseline, peaking approximately 24 hours after infusion. PK analysis demonstrated a half-life of 21 to 26 days, supporting a 13-week dosing interval for bapineuzumab. This small, single-dose study demonstrated the safety profile and PK characteristics of bapineuzumab and was used to design later safety and efficacy trials.
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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 [75]
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Metadata
- Authors
- Black, R. S., Sperling, R. A., Safirstein, B., Motter, R. N., Pallay, A., Nichols, A., & Grundman, M.
- Affiliations
- Wyeth (US)
- Brigham and Women's Hospital (US)
- Elan Pharmaceuticals, Inc. (Ireland) (IE)
- Corresponding author
- Black, Ronald S.
- Pallay, Allan
- Nichols, Alice
- ORCID
- Sperling, Reisa A.
- Venue
- Alzheimer Disease & Associated Disorders
- Published
- 2010-04
- Volume
- 24
- Issue
- 2
- Pages
- 198-203
- ISSN
- 0893-0341 (ISSN-L)
- PMC
- PMC3715117
- OpenAlex
- W1978924496
- Cited by
- 170
- References
- 16
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 13 · 2023: 9 · 2022: 12 · 2021: 6 · 2020: 10 · 2019: 4 · 2018: 6 · 2017: 10 · 2016: 16 · 2015: 6 · 2014: 12 · 2013: 15 · 2012: 15
- FWCI
- 11.05
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Alzheimer Disease & Associated Disorders (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Aging (P50AG005134)
- 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 › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
- Keywords
- bapineuzumab, Alzheimer's disease, amyloid-beta, humanized monoclonal antibody, pharmacokinetics, drug safety, tolerability, vasogenic edema, plasma amyloid-beta, single ascending dose, dosing interval
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Antibodies, Monoclonal, Dose-Response Relationship, Drug, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Neuropsychological Tests, Amyloid beta-Peptides, Nootropic Agents, Antibodies, Monoclonal, Humanized
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