作者
Anthony E Lang, Andrew D Siderowf, Eric A Macklin, Werner Poewe, David J Brooks, Hubert H Fernandez, Olivier Rascol, Nir Giladi, Fabrizio Stocchi, Caroline M Tanner, Ronald B Postuma, David K Simon, Eduardo Tolosa, Brit Mollenhauer, Jesse M Cedarbaum, Kyle Fraser, James Xiao, Karleyton C Evans, Danielle L Graham, Inbal Sapir, Jennifer Inra, R Matthew Hutchison, Minhua Yang, Tara Fox, Samantha Budd Haeberlein, Tien Dam
发表日期
2022/8/4
期刊
New England Journal of Medicine
卷号
387
期号
5
页码范围
408-420
出版商
Massachusetts Medical Society
简介
Background
Aggregated α-synuclein plays an important role in Parkinson’s disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson’s disease.
Methods
In a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson’s disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society–sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included …
引用总数
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AE Lang, AD Siderowf, EA Macklin, W Poewe… - New England Journal of Medicine, 2022