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@ARTICLE{Pagano:165174,
      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, Juergen 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},
      collaboration = {Investigators, PASADENA and Group, Prasinezumab Study},
      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     = {DZNE-2022-01476},
      pages        = {421 - 432},
      year         = {2022},
      abstract     = {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.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).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.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.).},
      keywords     = {Antibodies, Monoclonal, Humanized: therapeutic use /
                      Antiparkinson Agents: therapeutic use / Dopamine Plasma
                      Membrane Transport Proteins: therapeutic use / Double-Blind
                      Method / Humans / Parkinson Disease: drug therapy /
                      Treatment Outcome / alpha-Synuclein: antagonists $\&$
                      inhibitors / Antibodies, Monoclonal, Humanized (NLM
                      Chemicals) / Antiparkinson Agents (NLM Chemicals) / Dopamine
                      Plasma Membrane Transport Proteins (NLM Chemicals) /
                      alpha-Synuclein (NLM Chemicals)},
      cin          = {AG Gasser},
      ddc          = {610},
      cid          = {I:(DE-2719)1210000},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:35921451},
      doi          = {10.1056/NEJMoa2202867},
      url          = {https://pub.dzne.de/record/165174},
}