000909580 001__ 909580
000909580 005__ 20240109115058.0
000909580 0247_ $$2doi$$a10.1056/NEJMoa2202867
000909580 0247_ $$2ISSN$$a0028-4793
000909580 0247_ $$2ISSN$$a1533-4406
000909580 0247_ $$2datacite_doi$$a10.34734/FZJ-2022-03262
000909580 0247_ $$2pmid$$a35921451
000909580 0247_ $$2WOS$$aWOS:000861612100008
000909580 037__ $$aFZJ-2022-03262
000909580 082__ $$a610
000909580 1001_ $$0P:(DE-HGF)0$$aPagano, Gennaro$$b0$$eCorresponding author
000909580 245__ $$aTrial of Prasinezumab in Early-Stage Parkinson’s Disease
000909580 260__ $$aWaltham, Mass.$$bMMS$$c2022
000909580 3367_ $$2DRIVER$$aarticle
000909580 3367_ $$2DataCite$$aOutput Types/Journal article
000909580 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1702800103_26669
000909580 3367_ $$2BibTeX$$aARTICLE
000909580 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000909580 3367_ $$00$$2EndNote$$aJournal Article
000909580 520__ $$aBackground: 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.).
000909580 536__ $$0G:(DE-HGF)POF4-5251$$a5251 - Multilevel Brain Organization and Variability (POF4-525)$$cPOF4-525$$fPOF IV$$x0
000909580 536__ $$0G:(DE-HGF)POF4-5253$$a5253 - Neuroimaging (POF4-525)$$cPOF4-525$$fPOF IV$$x1
000909580 588__ $$aDataset connected to CrossRef, Journals: juser.fz-juelich.de
000909580 7001_ $$0P:(DE-HGF)0$$aTaylor, Kirsten I.$$b1
000909580 7001_ $$0P:(DE-HGF)0$$aAnzures-Cabrera, Judith$$b2
000909580 7001_ $$0P:(DE-HGF)0$$aMarchesi, Maddalena$$b3
000909580 7001_ $$0P:(DE-HGF)0$$aSimuni, Tanya$$b4
000909580 7001_ $$0P:(DE-HGF)0$$aMarek, Kenneth$$b5
000909580 7001_ $$0P:(DE-HGF)0$$aPostuma, Ronald B.$$b6
000909580 7001_ $$0P:(DE-HGF)0$$aPavese, Nicola$$b7
000909580 7001_ $$0P:(DE-HGF)0$$aStocchi, Fabrizio$$b8
000909580 7001_ $$0P:(DE-HGF)0$$aAzulay, Jean-Philippe$$b9
000909580 7001_ $$0P:(DE-HGF)0$$aMollenhauer, Brit$$b10
000909580 7001_ $$0P:(DE-HGF)0$$aLópez-Manzanares, Lydia$$b11
000909580 7001_ $$0P:(DE-HGF)0$$aRussell, David S.$$b12
000909580 7001_ $$0P:(DE-HGF)0$$aBoyd, James T.$$b13
000909580 7001_ $$0P:(DE-HGF)0$$aNicholas, Anthony P.$$b14
000909580 7001_ $$0P:(DE-HGF)0$$aLuquin, María R.$$b15
000909580 7001_ $$0P:(DE-HGF)0$$aHauser, Robert A.$$b16
000909580 7001_ $$0P:(DE-HGF)0$$aGasser, Thomas$$b17
000909580 7001_ $$0P:(DE-HGF)0$$aPoewe, Werner$$b18
000909580 7001_ $$0P:(DE-HGF)0$$aRicci, Benedicte$$b19
000909580 7001_ $$0P:(DE-HGF)0$$aBoulay, Anne$$b20
000909580 7001_ $$0P:(DE-HGF)0$$aVogt, Annamarie$$b21
000909580 7001_ $$0P:(DE-HGF)0$$aBoess, Frank G.$$b22
000909580 7001_ $$0P:(DE-Juel1)177727$$aDukart, Jürgen$$b23$$ufzj
000909580 7001_ $$0P:(DE-HGF)0$$aD’Urso, Giulia$$b24
000909580 7001_ $$0P:(DE-HGF)0$$aFinch, Rebecca$$b25
000909580 7001_ $$0P:(DE-HGF)0$$aZanigni, Stefano$$b26
000909580 7001_ $$0P:(DE-HGF)0$$aMonnet, Annabelle$$b27
000909580 7001_ $$0P:(DE-HGF)0$$aPross, Nathalie$$b28
000909580 7001_ $$0P:(DE-HGF)0$$aHahn, Andrea$$b29
000909580 7001_ $$0P:(DE-HGF)0$$aSvoboda, Hanno$$b30
000909580 7001_ $$0P:(DE-HGF)0$$aBritschgi, Markus$$b31
000909580 7001_ $$0P:(DE-HGF)0$$aLipsmeier, Florian$$b32
000909580 7001_ $$0P:(DE-HGF)0$$aVolkova-Volkmar, Ekaterina$$b33
000909580 7001_ $$0P:(DE-HGF)0$$aLindemann, Michael$$b34
000909580 7001_ $$0P:(DE-HGF)0$$aDziadek, Sebastian$$b35
000909580 7001_ $$0P:(DE-HGF)0$$aHoliga, Štefan$$b36
000909580 7001_ $$0P:(DE-HGF)0$$aRukina, Daria$$b37
000909580 7001_ $$0P:(DE-HGF)0$$aKustermann, Thomas$$b38
000909580 7001_ $$0P:(DE-HGF)0$$aKerchner, Geoffrey A.$$b39
000909580 7001_ $$0P:(DE-HGF)0$$aFontoura, Paulo$$b40
000909580 7001_ $$0P:(DE-HGF)0$$aUmbricht, Daniel$$b41
000909580 7001_ $$0P:(DE-HGF)0$$aDoody, Rachelle$$b42
000909580 7001_ $$0P:(DE-HGF)0$$aNikolcheva, Tania$$b43
000909580 7001_ $$0P:(DE-HGF)0$$aBonni, Azad$$b44
000909580 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$$y2022
000909580 8564_ $$uhttps://juser.fz-juelich.de/record/909580/files/nejmoa2202867.pdf$$yOpenAccess
000909580 8564_ $$uhttps://juser.fz-juelich.de/record/909580/files/nejmoa2202867.gif?subformat=icon$$xicon$$yOpenAccess
000909580 8564_ $$uhttps://juser.fz-juelich.de/record/909580/files/nejmoa2202867.jpg?subformat=icon-1440$$xicon-1440$$yOpenAccess
000909580 8564_ $$uhttps://juser.fz-juelich.de/record/909580/files/nejmoa2202867.jpg?subformat=icon-180$$xicon-180$$yOpenAccess
000909580 8564_ $$uhttps://juser.fz-juelich.de/record/909580/files/nejmoa2202867.jpg?subformat=icon-640$$xicon-640$$yOpenAccess
000909580 909CO $$ooai:juser.fz-juelich.de:909580$$pdnbdelivery$$pdriver$$pVDB$$popen_access$$popenaire
000909580 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Roche Innovation Center Basel$$b0
000909580 9101_ $$0I:(DE-588b)5008462-8$$6P:(DE-Juel1)177727$$aForschungszentrum Jülich$$b23$$kFZJ
000909580 9131_ $$0G:(DE-HGF)POF4-525$$1G:(DE-HGF)POF4-520$$2G:(DE-HGF)POF4-500$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$9G:(DE-HGF)POF4-5251$$aDE-HGF$$bKey Technologies$$lNatural, Artificial and Cognitive Information Processing$$vDecoding Brain Organization and Dysfunction$$x0
000909580 9131_ $$0G:(DE-HGF)POF4-525$$1G:(DE-HGF)POF4-520$$2G:(DE-HGF)POF4-500$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$9G:(DE-HGF)POF4-5253$$aDE-HGF$$bKey Technologies$$lNatural, Artificial and Cognitive Information Processing$$vDecoding Brain Organization and Dysfunction$$x1
000909580 9141_ $$y2022
000909580 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)1050$$2StatID$$aDBCoverage$$bBIOSIS Previews$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)1190$$2StatID$$aDBCoverage$$bBiological Abstracts$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0600$$2StatID$$aDBCoverage$$bEbsco Academic Search$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bNEW ENGL J MED : 2019$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0113$$2StatID$$aWoS$$bScience Citation Index Expanded$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0510$$2StatID$$aOpenAccess
000909580 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bASC$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)9970$$2StatID$$aIF >= 70$$bNEW ENGL J MED : 2019$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0160$$2StatID$$aDBCoverage$$bEssential Science Indicators$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)1110$$2StatID$$aDBCoverage$$bCurrent Contents - Clinical Medicine$$d2021-02-04
000909580 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List$$d2021-02-04
000909580 920__ $$lyes
000909580 9201_ $$0I:(DE-Juel1)INM-7-20090406$$kINM-7$$lGehirn & Verhalten$$x0
000909580 980__ $$ajournal
000909580 980__ $$aVDB
000909580 980__ $$aUNRESTRICTED
000909580 980__ $$aI:(DE-Juel1)INM-7-20090406
000909580 9801_ $$aFullTexts