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000165174 0247_ $$2doi$$a10.1056/NEJMoa2202867
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000165174 0247_ $$2ISSN$$a1533-4406
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000165174 037__ $$aDZNE-2022-01476
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000165174 1001_ $$aPagano, Gennaro$$b0
000165174 245__ $$aTrial of Prasinezumab in Early-Stage Parkinson's Disease.
000165174 260__ $$aWaltham, Mass.$$bMMS$$c2022
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000165174 520__ $$aAggregated 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.).
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000165174 650_7 $$2NLM Chemicals$$aAntibodies, Monoclonal, Humanized
000165174 650_7 $$2NLM Chemicals$$aAntiparkinson Agents
000165174 650_7 $$2NLM Chemicals$$aDopamine Plasma Membrane Transport Proteins
000165174 650_7 $$2NLM Chemicals$$aalpha-Synuclein
000165174 650_2 $$2MeSH$$aAntibodies, Monoclonal, Humanized: therapeutic use
000165174 650_2 $$2MeSH$$aAntiparkinson Agents: therapeutic use
000165174 650_2 $$2MeSH$$aDopamine Plasma Membrane Transport Proteins: therapeutic use
000165174 650_2 $$2MeSH$$aDouble-Blind Method
000165174 650_2 $$2MeSH$$aHumans
000165174 650_2 $$2MeSH$$aParkinson Disease: drug therapy
000165174 650_2 $$2MeSH$$aTreatment Outcome
000165174 650_2 $$2MeSH$$aalpha-Synuclein: antagonists & inhibitors
000165174 7001_ $$aTaylor, Kirsten I$$b1
000165174 7001_ $$aAnzures-Cabrera, Judith$$b2
000165174 7001_ $$aMarchesi, Maddalena$$b3
000165174 7001_ $$aSimuni, Tanya$$b4
000165174 7001_ $$0P:(DE-2719)9000201$$aMarek, Kenneth$$b5$$udzne
000165174 7001_ $$aPostuma, Ronald B$$b6
000165174 7001_ $$aPavese, Nicola$$b7
000165174 7001_ $$aStocchi, Fabrizio$$b8
000165174 7001_ $$aAzulay, Jean-Philippe$$b9
000165174 7001_ $$0P:(DE-2719)9001340$$aMollenhauer, Brit$$b10$$udzne
000165174 7001_ $$aLópez-Manzanares, Lydia$$b11
000165174 7001_ $$aRussell, David S$$b12
000165174 7001_ $$aBoyd, James T$$b13
000165174 7001_ $$aNicholas, Anthony P$$b14
000165174 7001_ $$aLuquin, María R$$b15
000165174 7001_ $$aHauser, Robert A$$b16
000165174 7001_ $$0P:(DE-2719)2320009$$aGasser, Thomas$$b17$$udzne
000165174 7001_ $$aPoewe, Werner$$b18
000165174 7001_ $$aRicci, Benedicte$$b19
000165174 7001_ $$aBoulay, Anne$$b20
000165174 7001_ $$aVogt, Annamarie$$b21
000165174 7001_ $$aBoess, Frank G$$b22
000165174 7001_ $$aDukart, Juergen$$b23
000165174 7001_ $$aD'Urso, Giulia$$b24
000165174 7001_ $$aFinch, Rebecca$$b25
000165174 7001_ $$aZanigni, Stefano$$b26
000165174 7001_ $$aMonnet, Annabelle$$b27
000165174 7001_ $$aPross, Nathalie$$b28
000165174 7001_ $$aHahn, Andrea$$b29
000165174 7001_ $$aSvoboda, Hanno$$b30
000165174 7001_ $$aBritschgi, Markus$$b31
000165174 7001_ $$aLipsmeier, Florian$$b32
000165174 7001_ $$aVolkova-Volkmar, Ekaterina$$b33
000165174 7001_ $$aLindemann, Michael$$b34
000165174 7001_ $$aDziadek, Sebastian$$b35
000165174 7001_ $$aHoliga, Štefan$$b36
000165174 7001_ $$aRukina, Daria$$b37
000165174 7001_ $$aKustermann, Thomas$$b38
000165174 7001_ $$aKerchner, Geoffrey A$$b39
000165174 7001_ $$aFontoura, Paulo$$b40
000165174 7001_ $$aUmbricht, Daniel$$b41
000165174 7001_ $$aDoody, Rachelle$$b42
000165174 7001_ $$aNikolcheva, Tania$$b43
000165174 7001_ $$aBonni, Azad$$b44
000165174 7001_ $$aInvestigators, PASADENA$$b45$$eCollaboration Author
000165174 7001_ $$aGroup, Prasinezumab Study$$b46$$eCollaboration Author
000165174 773__ $$0PERI:(DE-600)1468837-2$$a10.1056/NEJMoa2202867$$gVol. 387, no. 5, p. 421 - 432$$n5$$p421 - 432$$tThe New England journal of medicine$$v387$$x0028-4793$$y2022
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