{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T18:31:35Z","timestamp":1790188295828,"version":"4.1.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,2,2]],"date-time":"2023-02-02T00:00:00Z","timestamp":1675296000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Tau accumulation in patients with Alzheimer\u2019s disease tracks closely with cognitive decline and plays a role in the later stages of disease progression. This phase 2 study evaluated the safety and efficacy of tilavonemab, an anti-tau monoclonal antibody, in patients with early Alzheimer\u2019s disease.<\/jats:p>\n                  <jats:p>In this 96-week, randomized, double-blind, placebo-controlled study (NCT02880956), patients aged 55\u201385 years meeting clinical criteria for early Alzheimer\u2019s disease with a Clinical Dementia Rating-Global Score of 0.5, a Mini-Mental State Examination score of 22 to 30, a Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index score of \u226485, and a positive amyloid PET scan were randomized 1:1:1:1 to receive one of three doses of tilavonemab (300 mg, 1000 mg, or 2000 mg) or placebo via intravenous infusion every 4 weeks. The primary end point was the change from baseline up to Week 96 in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Safety evaluations included adverse event monitoring and MRI assessments.<\/jats:p>\n                  <jats:p>A total of 453 patients were randomized, of whom 337 were treated with tilavonemab (300 mg, n = 108; 1000 mg, n = 116; 2000 mg, n = 113) and 116 received placebo. Baseline demographics and disease characteristics were comparable across groups. The mean age was 71.3 (SD 7.0) years, 51.7% were female, and 96.5% were White. At baseline, the mean CDR-SB score was 3.0 (1.2), which worsened through Week 96 for all treatment groups. The least squares mean change from baseline at Week 96 in the CDR-SB score with tilavonemab was not significantly different compared with placebo [300 mg (n = 85): \u22120.07 (95% confidence interval, CI: \u22120.83 to 0.69); 1000 mg (n = 91): \u22120.06 (95% CI: \u22120.81 to 0.68); 2000 mg (n = 81): 0.16 (95% CI: \u22120.60 to 0.93); all P \u2265 0.05]. The incidence of any adverse event and MRI findings were generally comparable across groups.<\/jats:p>\n                  <jats:p>Tilavonemab was generally well tolerated but did not demonstrate efficacy in treating patients with early Alzheimer\u2019s disease. Further investigations of tilavonemab in early Alzheimer\u2019s disease are not warranted.<\/jats:p>","DOI":"10.1093\/brain\/awad024","type":"journal-article","created":{"date-parts":[[2023,1,24]],"date-time":"2023-01-24T08:12:01Z","timestamp":1674547921000},"page":"2275-2284","source":"Crossref","is-referenced-by-count":130,"title":["Tilavonemab in early Alzheimer\u2019s disease: results from a phase 2, randomized, double-blind study"],"prefix":"10.1093","volume":"146","author":[{"given":"Hana","family":"Florian","sequence":"first","affiliation":[{"name":"Neuroscience, AbbVie Inc. , North Chicago, IL 60064 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2474-6811","authenticated-orcid":false,"given":"Deli","family":"Wang","sequence":"additional","affiliation":[{"name":"Data and Statistical Sciences, AbbVie Inc. , North Chicago, IL 60064 , 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