{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T17:20:59Z","timestamp":1777396859185,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T00:00:00Z","timestamp":1734307200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100007013","name":"F. Hoffmann-La Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Alzheimer\u2019s Disease"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Gantenerumab is a fully human anti-amyloid-\u03b2 (A\u03b2) immunoglobulin G1 monoclonal antibody for subcutaneous (SC) administration. The efficacy and safety of low-dose (105\u2005mg or 225\u2005mg) gantenerumab were investigated in SCarlet RoAD (SR; NCT01224106), a Phase III, double-blind (DB), placebo-controlled study in participants with prodromal Alzheimer's disease. Following a pre-planned futility analysis, SR was converted into an open-label extension (OLE) study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the long-term safety and tolerability of SC gantenerumab at doses of up to 1200\u2005mg every 4 weeks (Q4W) in OLE participants who previously received placebo or gantenerumab in the DB part of SR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants of the DB part of SR, who met the eligibility criteria for the OLE, were offered the opportunity to receive gantenerumab up-titrated to 1200\u2005mg Q4W according to prespecified titration regimens. Safety and tolerability were assessed using magnetic resonance imaging (MRI), physical and neurologic examinations, and adverse event monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 154 participants were rolled over from the DB part of SR and received at least one dose of gantenerumab in the SR OLE. The median duration of treatment was 2.9 years (152.9 weeks). Forty-seven (30.5%) participants had an amyloid-related imaging abnormalities \u2013 edema (ARIA-E) MRI finding, and 51 (33.1%) had an ARIA \u2013 hemorrhage MRI finding. Most ARIA-E findings were asymptomatic and manageable by MRI monitoring and dose intervention. There were no unexpected safety findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SC gantenerumab at doses of up to 1200\u2005mg Q4W was well tolerated with no unexpected safety findings in participants with prodromal Alzheimer's disease.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial registration:<\/jats:bold>\n                      ClinicalTrials.gov ID NCT01224106\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13872877241303644","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T02:17:06Z","timestamp":1734401826000},"page":"528-541","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Long-term safety of gantenerumab in participants with Alzheimer's disease: A phase III, open-label extension study (SCarlet RoAD)"],"prefix":"10.1177","volume":"103","author":[{"given":"Merc\u00e8","family":"Boada","sequence":"first","affiliation":[{"name":"Ace Alzheimer Center Barcelona, Universitat Internacional de Catalunya, Barcelona, Spain"},{"name":"Networking Research Center on Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anuja","family":"Neve","sequence":"additional","affiliation":[{"name":"F. 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Dementia statistics https:\/\/www.alzint.org\/about\/dementia-facts-figures\/dementia-statistics\/ (2022 accessed 19 October 2023)."},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2100708"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2022.30"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212948"},{"key":"e_1_3_5_7_2","unstructured":"US Food and Drug Administration (FDA). FDA\u2019s Decision to Approve New Treatment for Alzheimer\u2019s Disease [press release]. June 7 2021 https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fdas-decision-approve-new-treatment-alzheimers-disease (2021 accessed 19 October 2023)."},{"key":"e_1_3_5_8_2","unstructured":"US Food and Drug Administration (FDA). FDA Converts Novel Alzheimer\u2019s Disease Treatment to Traditional Approval: Action Follows Confirmatory Trial to Verify Clinical Benefit [news release]. 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