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Gantenerumab: an an...
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Bateman, Randall J
(author)
Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease.
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2022-11-29
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Springer Science and Business Media LLC,2022
Numbers
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LIBRIS-ID:oai:gup.ub.gu.se/322184
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https://gup.ub.gu.se/publication/322184URI
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https://doi.org/10.1186/s13195-022-01110-8DOI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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This review describes the research and development process of gantenerumab, a fully human anti-amyloid monoclonal antibody in development to treat early symptomatic and asymptomatic Alzheimer's disease (AD). Anti-amyloid monoclonal antibodies can substantially reverse amyloid plaque pathology and may modify the course of the disease by slowing or stopping its clinical progression. Several molecules targeting amyloid have failed in clinical development due to drug-related factors (e.g., treatment-limiting adverse events, low potency, poor brain penetration), study design/methodological issues (e.g., disease stage, lack of AD pathology confirmation), and other factors. The US Food and Drug Administration's approval of aducanumab, an anti-amyloid monoclonal antibody as the first potential disease-modifying therapy for AD, signaled the value of more than 20 years of drug development, adding to the available therapies the first nominal success since cholinesterase inhibitors and memantine were approved. BODY: Here, we review over 2 decades of gantenerumab development in the context of scientific discoveries in the broader AD field. Key learnings from the field were incorporated into the gantenerumab phase 3 program, including confirmed amyloid positivity as an entry criterion, an enriched clinical trial population to ensure measurable clinical decline, data-driven exposure-response models to inform a safe and efficacious dosing regimen, and the use of several blood-based biomarkers. Subcutaneous formulation for more pragmatic implementation was prioritized as a key feature from the beginning of the gantenerumab development program.The results from the gantenerumab phase 3 programs are expected by the end of 2022 and will add critical information to the collective knowledge on the search for effective AD treatments.
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Cummings, Jeffrey
(author)
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Schobel, Scott
(author)
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Salloway, Stephen
(author)
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Vellas, Bruno
(author)
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Boada, Mercè
(author)
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Black, Sandra E
(author)
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Blennow, Kaj,1958Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry(Swepub:gu)xbleka
(author)
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Fontoura, Paulo
(author)
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Klein, Gregory
(author)
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Assunção, Sheila Seleri
(author)
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Smith, Janice
(author)
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Doody, Rachelle S
(author)
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Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi
(creator_code:org_t)
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In:Alzheimer's research & therapy: Springer Science and Business Media LLC14:11758-9193
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Bateman, Randall ...
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Cummings, Jeffre ...
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Schobel, Scott
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Salloway, Stephe ...
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Vellas, Bruno
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Boada, Mercè
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Black, Sandra E
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Blennow, Kaj, 19 ...
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Fontoura, Paulo
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Klein, Gregory
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Assunção, Sheila ...
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Smith, Janice
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Doody, Rachelle ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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and Basic Medicine
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and Neurosciences
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Alzheimer's rese ...
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University of Gothenburg