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000162743 037__ $$aDZNE-2021-01399
000162743 041__ $$aEnglish
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000162743 1001_ $$00000-0002-7786-5825$$aDam, Tien$$b0
000162743 245__ $$aSafety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
000162743 260__ $$aNew York, NY$$bNature America Inc.$$c2021
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000162743 520__ $$aA randomized, double-blind, placebo-controlled, 52-week study (no. NCT03068468) evaluated gosuranemab, an anti-tau monoclonal antibody, in the treatment of progressive supranuclear palsy (PSP). In total, 486 participants dosed were assigned to either gosuranemab (n = 321) or placebo (n = 165). Efficacy was not demonstrated on adjusted mean change of PSP Rating Scale score at week 52 between gosuranemab and placebo (10.4 versus 10.6, P = 0.85, primary endpoint), or at secondary endpoints, resulting in discontinuation of the open-label, long-term extension. Unbound N-terminal tau in cerebrospinal fluid decreased by 98% with gosuranemab and increased by 11% with placebo (P < 0.0001). Incidences of adverse events and deaths were similar between groups. This well-powered study suggests that N-terminal tau neutralization does not translate into clinical efficacy.
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000162743 650_7 $$2NLM Chemicals$$aAntibodies, Monoclonal, Humanized
000162743 650_7 $$2NLM Chemicals$$aMAPT protein, human
000162743 650_7 $$2NLM Chemicals$$atau Proteins
000162743 650_7 $$009FZ7Q0PQZ$$2NLM Chemicals$$agosuranemab
000162743 650_2 $$2MeSH$$aAged
000162743 650_2 $$2MeSH$$aAntibodies, Monoclonal, Humanized: adverse effects
000162743 650_2 $$2MeSH$$aAntibodies, Monoclonal, Humanized: therapeutic use
000162743 650_2 $$2MeSH$$aDouble-Blind Method
000162743 650_2 $$2MeSH$$aFemale
000162743 650_2 $$2MeSH$$aHumans
000162743 650_2 $$2MeSH$$aMale
000162743 650_2 $$2MeSH$$aPneumonia: etiology
000162743 650_2 $$2MeSH$$aSupranuclear Palsy, Progressive: drug therapy
000162743 650_2 $$2MeSH$$aTreatment Outcome
000162743 650_2 $$2MeSH$$atau Proteins: immunology
000162743 7001_ $$aBoxer, Adam L$$b1
000162743 7001_ $$aGolbe, Lawrence I$$b2
000162743 7001_ $$0P:(DE-2719)2811373$$aHöglinger, Günter$$b3$$udzne
000162743 7001_ $$00000-0002-5473-3774$$aMorris, Huw R$$b4
000162743 7001_ $$00000-0002-3485-3445$$aLitvan, Irene$$b5
000162743 7001_ $$aLang, Anthony E$$b6
000162743 7001_ $$aCorvol, Jean-Christophe$$b7
000162743 7001_ $$aAiba, Ikuko$$b8
000162743 7001_ $$aGrundman, Michael$$b9
000162743 7001_ $$aYang, Lili$$b10
000162743 7001_ $$aTidemann-Miller, Beth$$b11
000162743 7001_ $$aKupferman, Joseph$$b12
000162743 7001_ $$aHarper, Kristine$$b13
000162743 7001_ $$00000-0001-6620-0564$$aKamisoglu, Kubra$$b14
000162743 7001_ $$aWald, Michael J$$b15
000162743 7001_ $$aGraham, Danielle L$$b16
000162743 7001_ $$aGedney, Liz$$b17
000162743 7001_ $$aO'Gorman, John$$b18
000162743 7001_ $$aHaeberlein, Samantha Budd$$b19
000162743 7001_ $$aGroup, PASSPORT Study$$b20$$eCollaboration Author
000162743 773__ $$0PERI:(DE-600)1484517-9$$a10.1038/s41591-021-01455-x$$gVol. 27, no. 8, p. 1451 - 1457$$n8$$p1451 - 1457$$tNature medicine$$v27$$x1546-170X$$y2021
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