학술논문
Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
Document Type
article
Author
Dam, Tien; Boxer, Adam L; Golbe, Lawrence I; Höglinger, Günter U; Morris, Huw R; Litvan, Irene; Lang, Anthony E; Corvol, Jean-Christophe; Aiba, Ikuko; Grundman, Michael; Yang, Lili; Tidemann-Miller, Beth; Kupferman, Joseph; Harper, Kristine; Kamisoglu, Kubra; Wald, Michael J; Graham, Danielle L; Gedney, Liz; O'Gorman, John; Haeberlein, Samantha Budd; PASSPORT Study Group
Source
Nature medicine. 27(8)
Subject
Language
Abstract
A 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