期刊
NATURE MEDICINE
卷 27, 期 8, 页码 1451-+出版社
NATURE PORTFOLIO
DOI: 10.1038/s41591-021-01455-x
关键词
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资金
- Association for Frontotemporal Degeneration, Biogen, Bluefield Project to Cure Frontotemporal Dementia, Eli Lilly, Eisai, National Institutes of Health [U19AG063911, U54NS092089, R01AG031278]
- Tau Research Consortium
- AbbVie
- American Parkinson's Disease Association
- Biogen
- GE Health
- Neuropore
- German Research Foundation (DFG) [EXC 2145, 390857198, HO2402/6-2, HO2402/18-1]
- German Federal Ministry of Education and Research (BMBF) [01KU1403A, 01EK1605A]
- NOMIS foundation (FTLD project)
- EU/EFPIA/Innovative Medicines Initiative (2) Joint Undertaking (IMPRIND) [116060]
- VolkswagenStiftung/Lower Saxony Ministry for Science/Petermax-Muller Foundation (Niedersachsisches Vorab)
- CBD Solutions
- Cure Parkinson's Trust
- Drake Foundation
- Medical Research Council
- MND Association
- Parkinson's UK
- PSP Association
- method for diagnosing a neurodegenerative disease [PCT/GB2012/052140]
- Biohaven
- EIP-Pharma
- Roche
- Lewy Body Association
- Michael J. Fox Foundation
- National Institutes of Health [5P50AG005131-33, 2R01AG038791-06A, U01NS090259, U01NS100610, U01NS80818, R25NS098999, P20GM109025, U19AG063911-1, 1R21NS114764-01A1]
- Parkinson Foundation
- Parkinson Study Group
- University of California San Diego and Chief Editor of Frontiers in Neurology
- Actelion
In the conducted study, treatment with the anti-tau antibody gosuranemab for progressive supranuclear palsy did not show clinical benefit. Gosuranemab did not demonstrate efficacy compared to placebo in terms of PSP Rating Scale score and secondary endpoints. The study indicates that N-terminal tau neutralization does not result in clinical efficacy.
In the phase 2 PASSPORT study, treatment with the anti-tau antibody gosuranemab did not show clinical benefit in participants with supranuclear palsy, suggesting that N-terminal tau neutralization does not translate into clinical efficacy. 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 < 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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