Home > Publications Database > Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. > print

001     162743
005     20231205113438.0
024 7 _ |a 10.1038/s41591-021-01455-x
|2 doi
024 7 _ |a pmid:34385707
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024 7 _ |a 1078-8956
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024 7 _ |a 1546-170X
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037 _ _ |a DZNE-2021-01399
041 _ _ |a English
082 _ _ |a 610
100 1 _ |a Dam, Tien
|0 0000-0002-7786-5825
|b 0
245 _ _ |a Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
260 _ _ |a New York, NY
|c 2021
|b Nature America Inc.
336 7 _ |a article
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520 _ _ |a 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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588 _ _ |a Dataset connected to CrossRef, PubMed, , Journals: pub.dzne.de
650 _ 7 |a Antibodies, Monoclonal, Humanized
|2 NLM Chemicals
650 _ 7 |a MAPT protein, human
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650 _ 7 |a tau Proteins
|2 NLM Chemicals
650 _ 7 |a gosuranemab
|0 09FZ7Q0PQZ
|2 NLM Chemicals
650 _ 2 |a Aged
|2 MeSH
650 _ 2 |a Antibodies, Monoclonal, Humanized: adverse effects
|2 MeSH
650 _ 2 |a Antibodies, Monoclonal, Humanized: therapeutic use
|2 MeSH
650 _ 2 |a Double-Blind Method
|2 MeSH
650 _ 2 |a Female
|2 MeSH
650 _ 2 |a Humans
|2 MeSH
650 _ 2 |a Male
|2 MeSH
650 _ 2 |a Pneumonia: etiology
|2 MeSH
650 _ 2 |a Supranuclear Palsy, Progressive: drug therapy
|2 MeSH
650 _ 2 |a Treatment Outcome
|2 MeSH
650 _ 2 |a tau Proteins: immunology
|2 MeSH
700 1 _ |a Boxer, Adam L
|b 1
700 1 _ |a Golbe, Lawrence I
|b 2
700 1 _ |a Höglinger, Günter
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700 1 _ |a Morris, Huw R
|0 0000-0002-5473-3774
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700 1 _ |a Litvan, Irene
|0 0000-0002-3485-3445
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700 1 _ |a Lang, Anthony E
|b 6
700 1 _ |a Corvol, Jean-Christophe
|b 7
700 1 _ |a Aiba, Ikuko
|b 8
700 1 _ |a Grundman, Michael
|b 9
700 1 _ |a Yang, Lili
|b 10
700 1 _ |a Tidemann-Miller, Beth
|b 11
700 1 _ |a Kupferman, Joseph
|b 12
700 1 _ |a Harper, Kristine
|b 13
700 1 _ |a Kamisoglu, Kubra
|0 0000-0001-6620-0564
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700 1 _ |a Wald, Michael J
|b 15
700 1 _ |a Graham, Danielle L
|b 16
700 1 _ |a Gedney, Liz
|b 17
700 1 _ |a O'Gorman, John
|b 18
700 1 _ |a Haeberlein, Samantha Budd
|b 19
700 1 _ |a Group, PASSPORT Study
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|e Collaboration Author
773 _ _ |a 10.1038/s41591-021-01455-x
|g Vol. 27, no. 8, p. 1451 - 1457
|0 PERI:(DE-600)1484517-9
|n 8
|p 1451 - 1457
|t Nature medicine
|v 27
|y 2021
|x 1546-170X
856 4 _ |u https://pub.dzne.de/record/162743/files/DZNE-2021-01399_Restricted.pdf
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910 1 _ |a Deutsches Zentrum für Neurodegenerative Erkrankungen
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