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| Idioma original | Anglès |
|---|---|
| Revista | Frontiers in Neurology |
| Volum | 12 |
| DOIs | |
| Estat de la publicació | Publicada - 2021 |
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In: Frontiers in Neurology, Vol. 12, 2021.
Producció científica: Contribució a revista › Article › Recerca › Avaluat per experts
TY - JOUR
T1 - A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA) :
T2 - Rationale, Design, and Baseline Data
AU - Kulisevsky, Jaime
AU - Pagano, Gennaro
AU - Boess, Frank
AU - Taylor, Kirsten I.
AU - Ricci, Benedicte
AU - Mollenhauer, Brit
AU - Poewe, Werner
AU - Boulay, Anne
AU - Anzures-Cabrera, Judith
AU - Vogt, Annamarie
AU - Marchesi, Maddalena
AU - Post, Anke
AU - Nikolcheva, Tania
AU - Kinney, Gene G.
AU - Zago, Wagner M.
AU - Ness, Daniel K.
AU - Svoboda, Hanno
AU - Britschgi, Markus
AU - Ostrowitzki, Susanne
AU - Simuni, Tanya
AU - Marek, Kenneth
AU - Koller, Martin
AU - Sevigny, Jeff
AU - Doody, Rachelle
AU - Fontoura, Paulo
AU - Umbricht, Daniel
AU - Bonni, Azad
AU - Altendorf, Claudia
AU - Anandan, Chareyna
AU - Andrews, Giulia
AU - Ansquer, Solène
AU - Arrouasse, Raphaele
AU - Aslam, Sana
AU - Azulay, Jean-Philippe
AU - Baker, Jeanette
AU - Balaguer Martinez, Ernest
AU - Barbu, Shadi
AU - Bardram, Kara
AU - Bega, Danny
AU - Bejr-Kasem Marco, Helena
AU - Benatru, Isabelle
AU - Benchetrit, Eve
AU - Bernhard, Felix
AU - Besharat, Amir
AU - Bette, Sagari
AU - Bichon, Amelie
AU - Billnitzer, Andrew
AU - Blondeau, Sophie
AU - Boraud, Thomas
AU - Borngräber, Freiderike
AU - Boyd, James
AU - Brockmann, Kathrin
AU - Brodsky, Matthew
AU - Brown, Ethan
AU - Bruecke, Christof
AU - Calvas, Fabienne
AU - Canelo, Monica
AU - Carbone, Federico
AU - Carroll, Claire
AU - Casado Fernandez, Laura
AU - Cassé-Perrot, Catherine
AU - Castrioto, Anna
AU - Catala, Helene
AU - Chan, Justine
AU - Cheriet, Samia
AU - Ciabarra, Aanthony
AU - Classen, Joseph
AU - Coleman, Juliana
AU - Coleman, Robert
AU - Compta, Y.
AU - Corbillé, A.G.
AU - Corvol, Jean-Christophe
AU - Cosgaya, Marina
AU - Dahodwala, N.
AU - Damier, P.
AU - David, E.
AU - Davis, T.
AU - Dean, M.
AU - Debilly, B.
AU - DeGiorgio, J.
AU - Deik, A.
AU - Delaby, L.
AU - Delfini, M.H.
AU - Derkinderen, Pascal
AU - Derost, P.
AU - de Toledo, María
AU - Deuel, L.
AU - Diaz-Hernandez, A.M.
AU - Dietiker, C.
AU - Dimenshteyn, K.
AU - Dotor, J.
AU - Durif, F.
AU - Ebentheuer, J.
AU - Eggert, K.M.
AU - Eichau Madueño, Sara
AU - Eickhoff, C.
AU - Ellenbogen, A.
AU - Ellmerer, P.
AU - Esparragosa Vazquez, Inés
AU - Eusebio, A.
AU - Ewert, S.
AU - Fang, J.
AU - Feigenbaum, D.
AU - Fluchere, F.
AU - Foubert-Samier, A.
AU - Fournier, M.
AU - Fradet, A.
AU - Fraix, V.
AU - Frank, Samuel
AU - Fries, F.
AU - Galitzky, M.
AU - Gallardo Pérez, Marisol
AU - Moreno, J.M.G.
AU - Gasca, Carmen
AU - Gasser, T.
AU - Gibbons, J.
AU - Giordana, C.
AU - González Martinez, Alicia
AU - Goodman, I.
AU - Gorospe, A.
AU - Goubeaud, M.
AU - Grabli, D.
AU - Graziella, M.
AU - Grimaldi, S.
AU - Gross, J.
AU - Guimaraes-Costa, R.
AU - Hartmann, Andreas
AU - Hartmann, C.
AU - Hassell, T.
AU - Hauser, R.
AU - Hernandez, Antonio
AU - Hernandez-Vara, Jorge
AU - Hoeglinger, G.
AU - Homedes, C.
AU - Horta, Andrea
AU - Houeto, J.L.
AU - Huebl, J.
AU - Hui, J.
AU - Isaacson, S.
AU - Jankovic, J.
AU - Janzen, A.
AU - Jauregui, J.
AU - Jiao, J.
AU - Martí Domenech, María José
AU - Joseph, X.
AU - Kadimi, S.
AU - Kaminski, P.
AU - Kannenberg, S.
AU - Kassubek, J.
AU - Katz, M.
AU - Klos, K.
AU - Klos, S.
AU - Kobet, C.
AU - Koebert, J.
AU - Krause, P.
AU - Kuehn, A.
AU - Kumar, R.
AU - Kunz, M.
AU - Kurvits, L.
AU - Kwei, K.
AU - Laganiere, S.
AU - Laurens, B.
AU - Levin, J.
AU - Levy, O.
AU - LeWitt, P.
AU - Cristóbal, G.L.
AU - Litvan, I.
AU - Lizarraga, K.
AU - Longardner, K.
AU - Lopez, Rocío
AU - López Manzanares, Lydia
AU - Lucas del Pozo, Sara
AU - Luquín Pulido, María Rosario
AU - Luthra, N.
AU - Lyons, K.
AU - Maass, S.
AU - Machetanz, G.
AU - Macías, Y
AU - Maltete, D.
AU - Manez Miro, Jorge Uriel
AU - Mariani, Louise-Laure
AU - Marin, Juan
AU - Marini, K.
AU - Marques, Ana
AU - Marti, Gloria
AU - Martí Domenech, María José
AU - Martinez, Saul
AU - Meissner, W.
AU - Meoni, S.
AU - Mollenhauer, B.
AU - Martinez, D.M.
AU - Moon, J.
AU - Moro, Elena
AU - Morrison, P.
AU - Muehlberg, C.
AU - Multani, M.
AU - Murphy, C.
AU - Nicholas, A.
AU - Pahwa, R.
AU - Palasí Franco, Antoni
AU - Pape, H.
AU - Patel, N.
AU - Patel, P.
AU - Peball, M.
AU - Peckham, E.
AU - Peery, T.
AU - Perez, Rafael
AU - Perez, Jesús
AU - Petit, Alisa
AU - Pinkhardt, E.
AU - Poewe, W.
AU - Pomies, E.
AU - Preterre, C.
AU - Quinn, J.
AU - Rascol, O.
AU - Remy, P.
AU - Richard, I.
AU - Roeben, B.
AU - Ruether, E.
AU - Rumpf, J.J.
AU - Russell, D.
AU - Salhi, H.
AU - Samaniego-Toro, D.
AU - Samier-Foubert, A.
AU - Sánchez, Antonio
AU - Schmitt, E.
AU - Schnitzler, A.
AU - Schorr, O.
AU - Schwartzbard, J.
AU - Schweyer, K.
AU - Seppi, K.
AU - Sergo, V.
AU - Shill, H.
AU - Siderowf, A.
AU - Simuni, T.
AU - Spampinato, U.
AU - Sriram, A.
AU - Stover, N.
AU - Tanner, C.
AU - Tarakad, A.
AU - Taylor, C.
AU - Thalamus, C.
AU - Toothaker, T.
AU - Van Blercom, N.
AU - Vanegas-Arrogave, N.
AU - Vela, Lydia
AU - Vergnet, S.
AU - Vidal, T.
AU - Vöglein, J.
AU - Walsh, R.
AU - Waters, C.
AU - Wegscheider, M.
AU - Weidinger, E.
AU - Weill, C.
AU - Wenzel, G.
AU - Witjas, T.
AU - Wurster, I.
AU - Wright, B.
AU - Zimmermann, M.
AU - Zuzuarregui, R.
AU - Abt, M.
AU - Bamdadian, A.
AU - Barata, T.
AU - Barbet, N.
AU - Belli, S.
AU - Boess, Frank
AU - Bonni, Azad
AU - Borroni, E.
AU - Boulay, A.
AU - Britschgi, M.
AU - Chague, J.
AU - Cosson, V.
AU - Czech, C.
AU - Deptula, D.
AU - Diack, C.
AU - Doody, R.
AU - Dukart, J.
AU - D'Urso, G.
AU - Dziadek, S.
AU - Eddleston, H.
AU - Edgar, C.
AU - Essioux, L.
AU - Farell, M.
AU - Finch, R.
AU - Fontoura, P.
AU - Gruenbauer, W.
AU - Hahn, Andreas
AU - Holiga, S.
AU - Honer, M.
AU - Jadidi, S.
AU - Johnson-Wood, K.
AU - Keller, M.
AU - Kilchenmann, T.
AU - Koller, M.
AU - Kremer, T.
AU - Kustermann, T.
AU - Landsdall, C.
AU - Lindemann, M.
AU - Lipsmeier, F.
AU - Luzy, C.
AU - Manchester, M.
AU - Marchesi, M.
AU - Martenyi, F.
AU - Martin-Facklam, M.
AU - Mironova, K.
AU - Monnet, A.
AU - Moore, E.
AU - Ness, D.K.
AU - Niggli, M.
AU - Nikolcheva, T.
AU - Ostrowitzki, S.
AU - Pagano, G.
AU - Passmard, B.
AU - Poirier, A.
AU - Post, A.
AU - Prasad, M.
AU - Pross, N.
AU - Quock, T.
AU - Ricci, B.
AU - Rose, E.
AU - Sarry, C.
AU - Schubert, C.
AU - Selkoe, D.
AU - Sevigny, J.
AU - Sink, K.
AU - Staunton, H.
AU - Steven, T.
AU - Strasak, A.
AU - Svoboda, H.
AU - Taylor, K.
AU - Tripuraneni, R.
AU - Trundell, D.
AU - Umbricht, D.
AU - Verselis, L.
AU - Vogt, A.
AU - Volkova-Volkmar, E.
AU - Weber, C.
AU - Weber, S.
AU - Zago, W.
PY - 2021
Y1 - 2021
N2 - 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). The overall PASADENA population (63.6% treatment naïve and 36.4% on MAO-B inhibitor) showed a similar severity in MDS-UPDRS scores (e.g., MDS-UPDRS sum of Parts I + II + III [SD]; 31.41 [12.78], 32.63 [13.04], respectively) to the PPMI cohort (all treatment naïve). Conclusions: The PASADENA study population is suitable to investigate the potential of prasinezumab to slow disease progression in individuals with early PD. Trial Registration: NCT03100149.
AB - 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). The overall PASADENA population (63.6% treatment naïve and 36.4% on MAO-B inhibitor) showed a similar severity in MDS-UPDRS scores (e.g., MDS-UPDRS sum of Parts I + II + III [SD]; 31.41 [12.78], 32.63 [13.04], respectively) to the PPMI cohort (all treatment naïve). Conclusions: The PASADENA study population is suitable to investigate the potential of prasinezumab to slow disease progression in individuals with early PD. Trial Registration: NCT03100149.
KW - Parkinson's disease
KW - Alpha-synuclein (α-syn)
KW - Prasinezumab
KW - Monoclonal antibodies
KW - Disease progression
KW - MDS-UPDRS Movement Disorder Society-Unified Parkinson's Disease Rating Scale
KW - Phase II clinical trial
KW - Disease modification treatments
U2 - 10.3389/fneur.2021.705407
DO - 10.3389/fneur.2021.705407
M3 - Article
C2 - 34659081
SN - 1664-2295
VL - 12
JO - Frontiers in Neurology
JF - Frontiers in Neurology
ER -