| Title: |
A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA) : Rationale, Design, and Baseline Data |
| Authors: |
Pagano, Gennaro; Boess, Frank; Taylor, Kirsten I.; Ricci, Benedicte; Mollenhauer, Brit; Poewe, Werner; Boulay, Anne; Anzures-Cabrera, Judith; Vogt, Annamarie; Marchesi, Maddalena; Post, Anke; Nikolcheva, Tania; Kinney, Gene G.; Zago, Wagner M.; Ness, Daniel K.; Svoboda, Hanno; Britschgi, Markus; Ostrowitzki, Susanne; Simuni, Tanya; Marek, Kenneth; Koller, Martin; Sevigny, Jeff; Doody, Rachelle; Fontoura, Paulo; Umbricht, Daniel; Bonni, Azad; Altendorf, Claudia; Anandan, Chareyna; Andrews, Giulia; Ansquer, Solène; Arrouasse, Raphaele; Aslam, Sana; Azulay, Jean-Philippe; Baker, Jeanette; Balaguer, E.; Barbu, Shadi; Bardram, Kara; Bega, Danny; Bejr-kasem, Helena; Benatru, Isabelle; Benchetrit, Eve; Bernhard, Felix; Besharat, Amir; Bette, Sagari; Bichon, Amelie; Billnitzer, Andrew; Blondeau, Sophie; Boraud, Thomas; Borngräber, Freiderike; Boyd, James; Brockmann, Kathrin; Brodsky, Matthew; Brown, Ethan; Bruecke, Christof; Calvas, Fabienne; Canelo, Monica; Carbone, Federico; Carroll, Claire; Casado Fernandez, Laura; Cassé-Perrot, Catherine; Castrioto, Anna; Catala, Helene; Chan, Justine; Cheriet, Samia; Ciabarra, Aanthony; Classen, Joseph; Coleman, Juliana; Coleman, Robert; Compta, Yaroslau; Corbillé, Anne-Gaëlle; Corvol, Jean-Christophe; Cosgaya, Marina; Dahodwala, Nabila; Damier, Philippe; David, Elodie; Davis, Thomas; Dean, Marissa; Debilly, Berengere; DeGiorgio, Janell; Deik, Andres; Delaby, Laure; Delfini, Marie-Helene; Derkinderen, Pascal; Derost, Philipp; de Toledo, María; Deuel, Lisa; Diaz-Hernandez, Ann Marie; Dietiker, Cameron; Dimenshteyn, Karina; Dotor, Julio; Durif, Franck; Ebentheuer, Jens; Eggert, Karla Maria; Eichau Madueño, Sara; Eickhoff, Claudia; Ellenbogen, Aaron; Ellmerer, Philipp; Esparragosa Vazquez, Inés; Eusebio, Alexandre; Ewert, Siobhan; Fang, John; Feigenbaum, Danielle; Fluchere, Frederique; Foubert-Samier, Alexandra; Fournier, Marie; Fradet, Anne; Fraix, Valerie; Frank, Samuel; Fries, Franca; Galitzky, Monique; Gallardo Pérez, Marisol; Moreno, Jose Manuel García; Gasca, Carmen; Gasser, Thomas; Gibbons, Joyce; Giordana, Caroline; González Martinez, Alicia; Goodman, Ira; Gorospe, Arantza; Goubeaud, Marie; Grabli, David; Graziella, Mangone; Grimaldi, Stephan; Gross, Jeffrey; Guimaraes-Costa, Raquel; Hartmann, Andreas; Hartmann, Christian; Hassell, Travis; Hauser, Robert; Hernandez, Antonio; Hernández-Vara, Jorge; Hoeglinger, Günter; Homedes, Christian; Horta-Barba, Andrea; Houeto, Jean-Luc; Huebl, Julius; Hui, Jennifer; Isaacson, Stuart H.; Jankovic, Joseph; Janzen, Annette; Jauregui, Junior; Jiao, Jocelyne; Martí Domenech, María José; Joseph, Xavier; Kadimi, Srinath; Kaminski, Pat; Kannenberg, Silja; Kassubek, Jan; Katz, Maya; Klos, Kevin; Klos, Shannon; Kobet, Christopher; Koebert, Jennifer; Krause, Patricia; Kuehn, Andrea; Kulisevsky, Jaime; Kumar, Rajeev; Kunz, Martin; Kurvits, Lille; Kwei, Kimberly; Laganiere, Simon; Laurens, Brice; Levin, Johannes; Levy, Oren; LeWitt, Peter; Cristóbal, Gurutz Linazasoro; Litvan, Irene; Lizarraga, Karlo; Longardner, Katherine; Lopez, Rocío; López Manzanares, Lydia; Lucas del Pozo, Sara; Luquín Pulido, María Rosario; Luthra, Nijee; Lyons, Kelly; Maass, Sylvia; Machetanz, Gerrit; Macías, Yolanda; Maltete, David; Manez Miro, Jorge Uriel; Mariani, Louise-Laure; Marin, Juan; Marini, Kathrin; Marques, Ana; Marti, Gloria; Martinez, Saul; Meissner, Wassilios; Meoni, Sara; Mon Martinez, Dunia; Moon, Johnson; Moro, Elena; Morrison, Peter; Muehlberg, Christoph; Multani, Manpreet; Murphy, Christine; Nicholas, Anthony; Pahwa, Rajesh; Palasí Franco, Antoni; Pape, Heidi; Patel, Neepa; Patel, Prity; Peball, Marina; Peckham, Elizabeth; Peery, Terry; Perez, Rafael; Perez, Jesús; Petit, Alisa; Pinkhardt, Elmar; Pomies, Elsa; Preterre, Cecile; Quinn, Joseph; Rascol, Olivier; Remy, Philippe; Richard, Irene; Roeben, Benjamin; Ruether, Emily; Rumpf, Jost-Julian; Russell, David; Salhi, Hayet; Samaniego-Toro, Daniela; Samier-Foubert, Alexandra; Sánchez, Antonio; Schmitt, Emmanuelle; Schnitzler, Alfons; Schorr, Oliver; Schwartzbard, Julie; Schweyer, Kerstin; Seppi, Klaus; Sergo, Victoria; Shill, Holly; Siderowf, Andrew; Spampinato, Umberto; Sriram, Ashok; Stover, Natividad; Tanner, Caroline; Tarakad, Arjun; Taylor, Carolyn; Thalamus, Claire; Toothaker, Thomas; Van Blercom, Nadege; Vanegas-Arrogave, Nora; Vela, Lydia; Vergnet, Sylvian; Vidal, Tiphaine; Vöglein, Jonathan; Walsh, Ryan; Waters, Cheryl; Wegscheider, Mirko; Weidinger, Endy; Weill, Caroline; Wenzel, Gregor; Witjas, Tatiana; Wurster, Isabel; Wright, Brenton; Zimmermann, Milan; Zuzuarregui, Rafael; Abt, Markus; Bamdadian, Atieh; Barata, Teresa; Barbet, Nicholas; Belli, Sara; Borroni, Edilio; Chague, Jerome; Cosson, Valerie; Czech, Christian; Deptula, Dennis; Diack, Cheikh; Dukart, Juergen; D'Urso, Giulia; Dziadek, Sebastian; Eddleston, Hannah; Edgar, Chris; Essioux, Laurent; Farell, Morgan; Finch, Rebecca; Gruenbauer, Waltraud; Hahn, Andreas; Holiga, Stefan; Honer, Michael; Jadidi, Shirin; Johnson-Wood, Kelly; Keller, Markus; Kilchenmann, Timothy; Kremer, Thomas; Kustermann, Thomas; Landsdall, Claire; Lindemann, Michael; Lipsmeier, Florian; Luzy, Cecile; Manchester, Marianne; Martenyi, Ferenc; Martin-Facklam, Meret; Mironova, Katerina; Monnet, Annabelle; Moore, Emma; Niggli, Markus; Passmard, Benedicte; Poirier, Agnes; Prasad, Megana; Pross, Nathalie; Quock, Tiffany; Rose, Ellen; Sarry, Christoph; Schubert, Christine; Selkoe, Dennis; Sink, Kaycee; Staunton, Hannah; Steven, Tim; Strasak, Alexander; Tripuraneni, Radhika; Trundell, Dylan; Verselis, Lynne; Volkova-Volkmar, Ekaterina; Weber, Cornelia; Weber, Silke |
| Publication Year: |
2021 |
| Collection: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| Subject Terms: |
Parkinson's disease; Alpha-synuclein (α-syn); Prasinezumab; Monoclonal antibodies; Disease progression; MDS-UPDRS Movement Disorder Society-Unified Parkinson's Disease Rating Scale; Phase II clinical trial; Disease modification treatments |
| Description: |
Altres ajuts: F. Hoffmann-La Roche Ltd. ; Background: Currently available treatments for Parkinson's disease (PD) do not slow clinical progression nor target alpha-synuclein, a key protein associated with the disease. Objective: The study objective was to evaluate the efficacy and safety of prasinezumab, a humanized monoclonal antibody that binds aggregated alpha-synuclein, in individuals with early PD. Methods: The PASADENA study is a multicenter, randomized, double-blind, placebo-controlled treatment study. Individuals with early PD, recruited across the US and Europe, received monthly intravenous doses of prasinezumab (1,500 or 4,500 mg) or placebo for a 52-week period (Part 1), followed by a 52-week extension (Part 2) in which all participants received active treatment. Key inclusion criteria were: aged 40-80 years; Hoehn & Yahr (H&Y) Stage I or II; time from diagnosis ≤2 years; having bradykinesia plus one other cardinal sign of PD (e.g., resting tremor, rigidity); DAT-SPECT imaging consistent with PD; and either treatment naïve or on a stable monoamine oxidase B (MAO-B) inhibitor dose. Study design assumptions for sample size and study duration were built using a patient cohort from the Parkinson's Progression Marker Initiative (PPMI). In this report, baseline characteristics are compared between the treatment-naïve and MAO-B inhibitor-treated PASADENA cohorts and between the PASADENA and PPMI populations. Results: Of the 443 patients screened, 316 were enrolled into the PASADENA study between June 2017 and November 2018, with an average age of 59.9 years and 67.4% being male. Mean time from diagnosis at baseline was 10.11 months, with 75.3% in H&Y Stage II. Baseline motor and non-motor symptoms (assessed using Movement Disorder Society-Unified Parkinson's Disease Rating Scale [MDS-UPDRS]) were similar in severity between the MAO-B inhibitor-treated and treatment-naïve PASADENA cohorts (MDS-UPDRS sum of Parts I + II + III [standard deviation (SD)]; 30.21 [11.96], 32.10 [13.20], respectively). ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
16642295 |
| Relation: |
Frontiers in neurology; Vol. 12 (january 2021), p. 705407; https://ddd.uab.cat/record/270245; urn:10.3389/fneur.2021.705407; urn:oai:ddd.uab.cat:270245; urn:scopus_id:85117211748; urn:articleid:16642295v12a705407; urn:pmid:34659081; urn:pmcid:PMC8518716; urn:oai:pubmedcentral.nih.gov:8518716 |
| Availability: |
https://ddd.uab.cat/record/270245 |
| Rights: |
open access ; Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. ; https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.6516E00C |
| Database: |
BASE |