Cited by 172Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchMonoclonal and Polyclonal Antibodies Research

A Single Ascending Dose Study of Bapineuzumab in Patients With Alzheimer Disease

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Black, Ronald S., Sperling, Reisa A., Safirstein, Beth, Motter, Ruth N., Pallay, Allan, Nichols, Alice, Grundman, Michael·2010·Alzheimer Disease & Associated Disorders

Abstract

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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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
Venue
Alzheimer Disease & Associated Disorders
Published
2010-04
Volume
24
Issue
2
Pages
198-203
ISSN
0893-0341 (ISSN-L)
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
Locations
  • Alzheimer Disease & Associated Disorders (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute on Aging (P50AG005134)
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 › Radiology, Nuclear Medicine and Imaging › 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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