Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial

Autor:	Kubra Kamisoglu, Ikuko Aiba, Adam L. Boxer, Michael J Wald, Irene Litvan, Liz Gedney, Michael Grundman, Lili Yang, Danielle Graham, Tien Dam, Joseph Kupferman, Günter U. Höglinger, Anthony E. Lang, Kristine Harper, John O'Gorman, Beth Tidemann-Miller, Samantha Budd Haeberlein, Lawrence I. Golbe, Huw R. Morris, Jean-Christophe Corvol
Rok vydání:	2020
Předmět:	Male Placebo-controlled study adverse effects [Antibodies Monoclonal Humanized] Medical and Health Sciences Gastroenterology law.invention Randomized controlled trial law Monoclonal Clinical endpoint Supranuclear Palsy Humanized therapeutic use [Antibodies Monoclonal Humanized] General Medicine etiology [Pneumonia] Treatment Outcome 6.1 Pharmaceuticals Female Supranuclear Palsy Progressive medicine.medical_specialty drug therapy [Supranuclear Palsy Progressive] Clinical Trials and Supportive Activities Immunology MAPT protein human tau Proteins Placebo Antibodies Monoclonal Humanized Antibodies General Biochemistry Genetics and Molecular Biology Progressive supranuclear palsy Progressive Double-Blind Method Clinical Research Internal medicine medicine Humans ddc:610 Adverse effect Aged business.industry Evaluation of treatments and therapeutic interventions Pneumonia medicine.disease PASSPORT Study Group Brain Disorders Discontinuation immunology [tau Proteins] Clinical trial gosuranemab business
Zdroj:	Nature medicine 27(8), 1451-1457 (2021). doi:10.1038/s41591-021-01455-x Nature medicine, vol 27, iss 8
ISSN:	1546-170X
DOI:	10.1038/s41591-021-01455-x
Popis:	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
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::12fe1078c6e1b9326ff9a1875799321f https://pubmed.ncbi.nlm.nih.gov/36253611 Zobrazit plný text záznamu Full text from SpringerLink