First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease
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Abstract Introduction Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease‐modifying treatment for Alzheimer's disease (AD). Methods This randomized, double‐blind, placebo‐controlled single ascending‐dose study investigated the safety, tolerability, and pharmacokinetics (PK) of aducanumab in patients with mild‐to‐moderate AD. Eligible patients were sequentially randomized 6:2 to aducanumab (0.3, 1, 3, 10, 20, 30, and 60 mg/kg) or placebo. Results The primary outcome was safety and tolerability. Doses ≤30 mg/kg were generally well tolerated with no severe or serious adverse events (SAEs). All three patients who received 60 mg/kg aducanumab developed SAEs of symptomatic amyloid‐related imaging abnormalities, which completely resolved by weeks 8–15. Aducanumab C max , AUC 0–last , and AUC inf increased in a dose‐proportional manner. Discussion In this single‐dose study, aducanumab demonstrated an acceptable safety and tolerability profile and linear PK at doses ≤30 mg/kg ( clinicaltrials.gov NCT01397539 ).
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Aducanumab treatment lowers amyloid-β according to animal reports, while human trials revealed no substantial improvements in amyloid-40 and amyloid-42.
“Acurenumab treatment lowers amyloid-, according to reports from animals and while human trials revealed no substantial improvements in amyloid-40 and amyloid-42 (Ferrero et al., 2016).”
From An update on the novel and approved drugs for Alzheimer disease (2022) · cites this paper as Ferrero et al., 2016
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- Authors
- Ferrero, J., Williams, L., Stella, H., Leitermann, K., Mikulskis, A., O'Gorman, J., & Sevigny, J.
- Affiliations
- Biogen (United States) (US)
- Corresponding author
- Ferrero, James
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2016-06-20
- Volume
- 2
- Issue
- 3
- Pages
- 169-176
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC5651340
- OpenAlex
- W2466890096
- Cited by
- 189
- References
- 21
- Citations by year
- 2026: 17 · 2025: 12 · 2024: 29 · 2023: 24 · 2022: 52 · 2021: 23 · 2020: 12 · 2019: 9 · 2018: 4 · 2017: 4 · 2016: 1 · 2013: 1
- FWCI
- 4.79
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Biogen
- 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
- aducanumab, Alzheimer's disease, amyloid-beta aggregation, anti-amyloid monoclonal antibodies, disease-modifying therapy, safety and tolerability, pharmacokinetics, dose escalation, amyloid-related imaging abnormalities, first-in-human
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