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@ARTICLE{Pagano:909580,
      author       = {Pagano, Gennaro and Taylor, Kirsten I. and Anzures-Cabrera,
                      Judith and Marchesi, Maddalena and Simuni, Tanya and Marek,
                      Kenneth and Postuma, Ronald B. and Pavese, Nicola and
                      Stocchi, Fabrizio and Azulay, Jean-Philippe and Mollenhauer,
                      Brit and López-Manzanares, Lydia and Russell, David S. and
                      Boyd, James T. and Nicholas, Anthony P. and Luquin, María
                      R. and Hauser, Robert A. and Gasser, Thomas and Poewe,
                      Werner and Ricci, Benedicte and Boulay, Anne and Vogt,
                      Annamarie and Boess, Frank G. and Dukart, Jürgen and
                      D’Urso, Giulia and Finch, Rebecca and Zanigni, Stefano and
                      Monnet, Annabelle and Pross, Nathalie and Hahn, Andrea and
                      Svoboda, Hanno and Britschgi, Markus and Lipsmeier, Florian
                      and Volkova-Volkmar, Ekaterina and Lindemann, Michael and
                      Dziadek, Sebastian and Holiga, Štefan and Rukina, Daria and
                      Kustermann, Thomas and Kerchner, Geoffrey A. and Fontoura,
                      Paulo and Umbricht, Daniel and Doody, Rachelle and
                      Nikolcheva, Tania and Bonni, Azad},
      title        = {{T}rial of {P}rasinezumab in {E}arly-{S}tage
                      {P}arkinson’s {D}isease},
      journal      = {The New England journal of medicine},
      volume       = {387},
      number       = {5},
      issn         = {0028-4793},
      address      = {Waltham, Mass.},
      publisher    = {MMS},
      reportid     = {FZJ-2022-03262},
      pages        = {421 - 432},
      year         = {2022},
      abstract     = {Background: Aggregated α-synuclein plays an important role
                      in the pathogenesis of Parkinson's disease. The monoclonal
                      antibody prasinezumab, directed at aggregated α-synuclein,
                      is being studied for its effect on Parkinson's
                      disease.Methods: In this phase 2 trial, we randomly assigned
                      participants with early-stage Parkinson's disease in a 1:1:1
                      ratio to receive intravenous placebo or prasinezumab at a
                      dose of 1500 mg or 4500 mg every 4 weeks for 52 weeks. The
                      primary end point was the change from baseline to week 52 in
                      the sum of scores on parts I, II, and III of the Movement
                      Disorder Society-sponsored revision of the Unified
                      Parkinson's Disease Rating Scale (MDS-UPDRS; range, 0 to
                      236, with higher scores indicating greater impairment).
                      Secondary end points included the dopamine transporter
                      levels in the putamen of the hemisphere ipsilateral to the
                      clinically more affected side of the body, as measured by
                      123I-ioflupane single-photon-emission computed tomography
                      (SPECT).Results: A total of 316 participants were enrolled;
                      105 were assigned to receive placebo, 105 to receive 1500 mg
                      of prasinezumab, and 106 to receive 4500 mg of prasinezumab.
                      The baseline mean MDS-UPDRS scores were 32.0 in the placebo
                      group, 31.5 in the 1500-mg group, and 30.8 in the 4500-mg
                      group, and mean (±SE) changes from baseline to 52 weeks
                      were 9.4±1.2 in the placebo group, 7.4±1.2 in the 1500-mg
                      group (difference vs. placebo, -2.0; $80\%$ confidence
                      interval [CI], -4.2 to 0.2; P = 0.24), and 8.8±1.2 in the
                      4500-mg group (difference vs. placebo, -0.6; $80\%$ CI, -2.8
                      to 1.6; P = 0.72). There was no substantial difference
                      between the active-treatment groups and the placebo group in
                      dopamine transporter levels on SPECT. The results for most
                      clinical secondary end points were similar in the
                      active-treatment groups and the placebo group. Serious
                      adverse events occurred in $6.7\%$ of the participants in
                      the 1500-mg group and in $7.5\%$ of those in the 4500-mg
                      group; infusion reactions occurred in $19.0\%$ and $34.0\%,$
                      respectively.Conclusions: Prasinezumab therapy had no
                      meaningful effect on global or imaging measures of
                      Parkinson's disease progression as compared with placebo and
                      was associated with infusion reactions. (Funded by F.
                      Hoffmann-La Roche and Prothena Biosciences; PASADENA
                      ClinicalTrials.gov number, NCT03100149.).},
      cin          = {INM-7},
      ddc          = {610},
      cid          = {I:(DE-Juel1)INM-7-20090406},
      pnm          = {5251 - Multilevel Brain Organization and Variability
                      (POF4-525) / 5253 - Neuroimaging (POF4-525)},
      pid          = {G:(DE-HGF)POF4-5251 / G:(DE-HGF)POF4-5253},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {35921451},
      UT           = {WOS:000861612100008},
      doi          = {10.1056/NEJMoa2202867},
      url          = {https://juser.fz-juelich.de/record/909580},
}