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@ARTICLE{Dam:162743,
      author       = {Dam, Tien and Boxer, Adam L and Golbe, Lawrence I and
                      Höglinger, Günter and Morris, Huw R and Litvan, Irene and
                      Lang, Anthony E and Corvol, Jean-Christophe and Aiba, Ikuko
                      and Grundman, Michael and Yang, Lili and Tidemann-Miller,
                      Beth and Kupferman, Joseph and Harper, Kristine and
                      Kamisoglu, Kubra and Wald, Michael J and Graham, Danielle L
                      and Gedney, Liz and O'Gorman, John and Haeberlein, Samantha
                      Budd},
      collaboration = {Group, PASSPORT Study},
      title        = {{S}afety and efficacy of anti-tau monoclonal antibody
                      gosuranemab in progressive supranuclear palsy: a phase 2,
                      randomized, placebo-controlled trial.},
      journal      = {Nature medicine},
      volume       = {27},
      number       = {8},
      issn         = {1546-170X},
      address      = {New York, NY},
      publisher    = {Nature America Inc.},
      reportid     = {DZNE-2021-01399},
      pages        = {1451 - 1457},
      year         = {2021},
      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 < 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.},
      keywords     = {Aged / Antibodies, Monoclonal, Humanized: adverse effects /
                      Antibodies, Monoclonal, Humanized: therapeutic use /
                      Double-Blind Method / Female / Humans / Male / Pneumonia:
                      etiology / Supranuclear Palsy, Progressive: drug therapy /
                      Treatment Outcome / tau Proteins: immunology / Antibodies,
                      Monoclonal, Humanized (NLM Chemicals) / MAPT protein, human
                      (NLM Chemicals) / tau Proteins (NLM Chemicals) / gosuranemab
                      (NLM Chemicals)},
      cin          = {Clinical Research (Munich)},
      ddc          = {610},
      cid          = {I:(DE-2719)1111015},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:34385707},
      doi          = {10.1038/s41591-021-01455-x},
      url          = {https://pub.dzne.de/record/162743},
}