Trial of Cinpanemab in Early Parkinson’s Disease
AbstractBackgroundAggregated α-synuclein plays an important role in Parkinson’s disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson’s disease.MethodsIn a 52-week, multicenter, double-blind,...
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| Published in | The New England journal of medicine Vol. 387; no. 5; pp. 408 - 420 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston
Massachusetts Medical Society
04.08.2022
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| Subjects | |
| Online Access | Get full text |
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| Abstract | AbstractBackgroundAggregated α-synuclein plays an important role in Parkinson’s disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson’s disease.MethodsIn a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson’s disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society–sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included MDS-UPDRS subscale scores and striatal binding as assessed on dopamine transporter single-photon-emission computed tomography (DaT-SPECT).ResultsOf the 357 enrolled participants, 100 were assigned to the control group, 55 to the 250-mg cinpanemab group, 102 to the 1250-mg group, and 100 to the 3500-mg group. The trial was stopped after the week 72 interim analysis owing to lack of efficacy. The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, −0.3 points [95% confidence interval {CI}, −4.9 to 4.3], P=0.90; 0.5 points [95% CI, −3.3 to 4.3], P=0.80; and 0.1 point [95% CI, −3.8 to 4.0], P=0.97, respectively). The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was −0.9 points (95% CI, −5.6 to 3.8) for the 250-mg dose, 0.6 points (95% CI, −3.3 to 4.4) for the 1250-mg dose, and −0.8 points (95% CI, −4.6 to 3.0) for the 3500-mg dose. Results for secondary end points were similar to those for the primary end points. DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group. The most common adverse events with cinpanemab were headache, nasopharyngitis, and falls.ConclusionsIn participants with early Parkinson’s disease, the effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo over a 52-week period. (Funded by Biogen; SPARK ClinicalTrials.gov number, NCT03318523.) |
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| AbstractList | AbstractBackgroundAggregated α-synuclein plays an important role in Parkinson’s disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson’s disease.MethodsIn a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson’s disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society–sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included MDS-UPDRS subscale scores and striatal binding as assessed on dopamine transporter single-photon-emission computed tomography (DaT-SPECT).ResultsOf the 357 enrolled participants, 100 were assigned to the control group, 55 to the 250-mg cinpanemab group, 102 to the 1250-mg group, and 100 to the 3500-mg group. The trial was stopped after the week 72 interim analysis owing to lack of efficacy. The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, −0.3 points [95% confidence interval {CI}, −4.9 to 4.3], P=0.90; 0.5 points [95% CI, −3.3 to 4.3], P=0.80; and 0.1 point [95% CI, −3.8 to 4.0], P=0.97, respectively). The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was −0.9 points (95% CI, −5.6 to 3.8) for the 250-mg dose, 0.6 points (95% CI, −3.3 to 4.4) for the 1250-mg dose, and −0.8 points (95% CI, −4.6 to 3.0) for the 3500-mg dose. Results for secondary end points were similar to those for the primary end points. DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group. The most common adverse events with cinpanemab were headache, nasopharyngitis, and falls.ConclusionsIn participants with early Parkinson’s disease, the effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo over a 52-week period. (Funded by Biogen; SPARK ClinicalTrials.gov number, NCT03318523.) Aggregated α-synuclein plays an important role in Parkinson's disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson's disease.BACKGROUNDAggregated α-synuclein plays an important role in Parkinson's disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson's disease.In a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson's disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included MDS-UPDRS subscale scores and striatal binding as assessed on dopamine transporter single-photon-emission computed tomography (DaT-SPECT).METHODSIn a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson's disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included MDS-UPDRS subscale scores and striatal binding as assessed on dopamine transporter single-photon-emission computed tomography (DaT-SPECT).Of the 357 enrolled participants, 100 were assigned to the control group, 55 to the 250-mg cinpanemab group, 102 to the 1250-mg group, and 100 to the 3500-mg group. The trial was stopped after the week 72 interim analysis owing to lack of efficacy. The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, -0.3 points [95% confidence interval {CI}, -4.9 to 4.3], P = 0.90; 0.5 points [95% CI, -3.3 to 4.3], P = 0.80; and 0.1 point [95% CI, -3.8 to 4.0], P = 0.97, respectively). The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was -0.9 points (95% CI, -5.6 to 3.8) for the 250-mg dose, 0.6 points (95% CI, -3.3 to 4.4) for the 1250-mg dose, and -0.8 points (95% CI, -4.6 to 3.0) for the 3500-mg dose. Results for secondary end points were similar to those for the primary end points. DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group. The most common adverse events with cinpanemab were headache, nasopharyngitis, and falls.RESULTSOf the 357 enrolled participants, 100 were assigned to the control group, 55 to the 250-mg cinpanemab group, 102 to the 1250-mg group, and 100 to the 3500-mg group. The trial was stopped after the week 72 interim analysis owing to lack of efficacy. The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, -0.3 points [95% confidence interval {CI}, -4.9 to 4.3], P = 0.90; 0.5 points [95% CI, -3.3 to 4.3], P = 0.80; and 0.1 point [95% CI, -3.8 to 4.0], P = 0.97, respectively). The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was -0.9 points (95% CI, -5.6 to 3.8) for the 250-mg dose, 0.6 points (95% CI, -3.3 to 4.4) for the 1250-mg dose, and -0.8 points (95% CI, -4.6 to 3.0) for the 3500-mg dose. Results for secondary end points were similar to those for the primary end points. DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group. The most common adverse events with cinpanemab were headache, nasopharyngitis, and falls.In participants with early Parkinson's disease, the effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo over a 52-week period. (Funded by Biogen; SPARK ClinicalTrials.gov number, NCT03318523.).CONCLUSIONSIn participants with early Parkinson's disease, the effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo over a 52-week period. (Funded by Biogen; SPARK ClinicalTrials.gov number, NCT03318523.). In a phase 2 trial in early Parkinson’s disease, treatment with cinpanemab, a monoclonal antibody to α-synuclein, did not affect clinical or imaging progression over a period of 72 weeks. |
| Author | Graham, Danielle L. Stocchi, Fabrizio Hutchison, R. Matthew Cedarbaum, Jesse M. Yang, Minhua Brooks, David J. Macklin, Eric A. Inra, Jennifer Giladi, Nir Lang, Anthony E. Fraser, Kyle Tanner, Caroline M. Mollenhauer, Brit Fox, Tara Siderowf, Andrew D. Postuma, Ronald B. Simon, David K. Dam, Tien Budd Haeberlein, Samantha Xiao, James Evans, Karleyton C. Tolosa, Eduardo Poewe, Werner Sapir, Inbal Rascol, Olivier Fernandez, Hubert H. |
| Author_xml | – sequence: 1 givenname: Anthony E. surname: Lang fullname: Lang, Anthony E. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 2 givenname: Andrew D. surname: Siderowf fullname: Siderowf, Andrew D. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 3 givenname: Eric A. surname: Macklin fullname: Macklin, Eric A. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 4 givenname: Werner surname: Poewe fullname: Poewe, Werner organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 5 givenname: David J. surname: Brooks fullname: Brooks, David J. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 6 givenname: Hubert H. surname: Fernandez fullname: Fernandez, Hubert H. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 7 givenname: Olivier surname: Rascol fullname: Rascol, Olivier organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 8 givenname: Nir surname: Giladi fullname: Giladi, Nir organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 9 givenname: Fabrizio surname: Stocchi fullname: Stocchi, Fabrizio organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 10 givenname: Caroline M. surname: Tanner fullname: Tanner, Caroline M. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 11 givenname: Ronald B. surname: Postuma fullname: Postuma, Ronald B. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 12 givenname: David K. surname: Simon fullname: Simon, David K. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 13 givenname: Eduardo surname: Tolosa fullname: Tolosa, Eduardo organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 14 givenname: Brit surname: Mollenhauer fullname: Mollenhauer, Brit organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 15 givenname: Jesse M. surname: Cedarbaum fullname: Cedarbaum, Jesse M. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 16 givenname: Kyle surname: Fraser fullname: Fraser, Kyle organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 17 givenname: James surname: Xiao fullname: Xiao, James organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 18 givenname: Karleyton C. surname: Evans fullname: Evans, Karleyton C. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 19 givenname: Danielle L. surname: Graham fullname: Graham, Danielle L. organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 20 givenname: Inbal surname: Sapir fullname: Sapir, Inbal organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 21 givenname: Jennifer surname: Inra fullname: Inra, Jennifer organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 22 givenname: R. Matthew surname: Hutchison fullname: Hutchison, R. Matthew organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 23 givenname: Minhua surname: Yang fullname: Yang, Minhua organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 24 givenname: Tara surname: Fox fullname: Fox, Tara organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 25 givenname: Samantha surname: Budd Haeberlein fullname: Budd Haeberlein, Samantha organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) – sequence: 26 givenname: Tien surname: Dam fullname: Dam, Tien organization: From the Edmond J. Safra Program in Parkinson’s Disease, University Health Network, and the University of Toronto, Toronto (A.E.L.), and the Montreal Neurological Institute, Montreal (R.B.P.); the University of Pennsylvania, Philadelphia (A.D.S.); the Biostatistics Center, Massachusetts General Hospital (E.A.M.), Beth Israel Deaconess Medical Center (D.K.S.), and Harvard Medical School (E.A.M., D.K.S.), Boston, and Biogen, Cambridge (K.F., J.X., K.C.E., D.L.G., I.S., J.I., R.M.H., M.Y., S.B.H., T.D.) — all in Massachusetts; Medizinische Universität Innsbruck, Innsbruck, Austria (W.P.); Newcastle University, Newcastle upon Tyne (D.J.B.), and Biogen, Maidenhead (T.F.) — both in the United Kingdom; Aarhus University, Aarhus, Denmark (D.J.B.); the Center for Neurological Restoration, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine — both in Cleveland (H.H.F.); Clinical Investigation Center 1436, the Departments of Clinical Pharmacology and Neurosciences, NS-PARK–French Clinical Research Infrastructure Network, NeuroToul COEN Center, INSERM, University Hospital of Toulouse, and the University of Toulouse III — both in Toulouse, France (O.R.); Tel Aviv Sourasky Medical Center, and the Sackler School of Medicine and the Sagol School of Neuroscience, Tel Aviv University — both in Tel Aviv, Israel (N.G.); University San Raffaele and IRCCS San Raffaele — both in Rome (F.S.); the University of California, San Diego, La Jolla (C.M.T.), and the San Francisco Veterans Affairs Medical Center, San Francisco (C.M.T.); the University of Barcelona, Barcelona (E.T.); the Department of Neurology, University Medical Center Göttingen, Göttingen, and Paracelsus-Elena-Klinik, Kassel — both in Germany (B.M.); and Coeruleus Clinical Sciences, Woodbridge, CT (J.M.C.) |
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| Snippet | In a phase 2 trial in early Parkinson’s disease, treatment with cinpanemab, a monoclonal antibody to α-synuclein, did not affect clinical or imaging... AbstractBackgroundAggregated α-synuclein plays an important role in Parkinson’s disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that... Aggregated α-synuclein plays an important role in Parkinson's disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein,... |
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| SubjectTerms | Aging Aging General Clinical trials Cognitive ability Computed tomography Coronaviruses COVID-19 Dopamine Dopamine transporter Geriatrics Intravenous administration Laboratories Magnetic resonance imaging Medical research Monoclonal antibodies Movement disorders Neostriatum Neurodegenerative diseases Neurology Neurosurgery Parkinson Disease Parkinson's disease Pharmacokinetics Placebos Rhinopharyngitis Single photon emission computed tomography Synuclein |
| SubjectTermsDisplay | Geriatrics/Aging Geriatrics/Aging General Neurology/Neurosurgery Parkinson Disease |
| Title | Trial of Cinpanemab in Early Parkinson’s Disease |
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