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Sökning: id:"swepub:oai:gup.ub.gu.se/322184" > Gantenerumab: an an...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00004097naa a2200529 4500
001oai:gup.ub.gu.se/322184
003SwePub
008240528s2022 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/3221842 URI
0247 a https://doi.org/10.1186/s13195-022-01110-82 DOI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Bateman, Randall J4 aut
2451 0a Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease.
264 c 2022-11-29
264 1b Springer Science and Business Media LLC,c 2022
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Neurovetenskaper0 (SwePub)301052 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Neurosciences0 (SwePub)301052 hsv//eng
653 a United States
653 a Humans
653 a Alzheimer Disease
653 a drug therapy
653 a Amyloidogenic Proteins
653 a Amyloidosis
653 a Plaque
653 a Amyloid
653 a Asymptomatic Diseases
7001 a Cummings, Jeffrey4 aut
7001 a Schobel, Scott4 aut
7001 a Salloway, Stephen4 aut
7001 a Vellas, Bruno4 aut
7001 a Boada, Mercè4 aut
7001 a Black, Sandra E4 aut
7001 a Blennow, Kaj,d 1958u Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry4 aut0 (Swepub:gu)xbleka
7001 a Fontoura, Paulo4 aut
7001 a Klein, Gregory4 aut
7001 a Assunção, Sheila Seleri4 aut
7001 a Smith, Janice4 aut
7001 a Doody, Rachelle S4 aut
7102 a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi4 org
7730 t Alzheimer's research & therapyd : Springer Science and Business Media LLCg 14:1q 14:1x 1758-9193
8564 8u https://gup.ub.gu.se/publication/322184
8564 8u https://doi.org/10.1186/s13195-022-01110-8

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