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1. Effect of Urate-Elevating Inosine on Early Parkinson Disease Progression: The SURE-PD3 Randomized Clinical Trial

Author

Tanya Simuni, Holly A. Shill, Matthew Brodsky, Marcie Rabin, Michael A. Schwarzschild, Kenneth Marek, Cheryl Waters, Cindy Casaceli, Steven A. Gunzler, Stephen G. Reich, Codrin Lungu, Sarah Elizabeth Zauber, Kellie Keith, Shyamal H. Mehta, Dariush Mozaffarian, Valerie Suski, Marie Saint-Hilaire, John L. Goudreau, Alice Rudolph, Ruth B. Schneider, Aaron Daley, Eric A. Macklin, Zoltan Mari, Grace F. Crotty, Andres Deik, Alberto J. Espay, Ashley Laroche, Sherri Mosovsky, Joohi Jimenez-Shahed, Mark S. LeDoux, Cynthia Poon, Ashley Gerald, John C. Morgan, Carolyn Peterson, Joseph H. Friedman, David Klements, Robert A. Hauser, Doozie Russell, David Simon, Kathrin LaFaver, Vanessa K. Hinson, Richard B. Dewey, Melissa Ainslie, Jason Aldred, Tiago A. Mestre, John Y. Fang, Liana S. Rosenthal, Grace Bwala, Raymond C. James, Binit B. Shah, Gearoid M. McMahon, Ariane Park, Rajeev Kumar, Lin Zhang, Ivan Bodis-Wollner, Mya C. Schiess, Katherine F. Callahan, David Oakes, Kelvin L. Chou, Melissa Kostrzebski, Roger Kurlan, Lisa Gauger, Albert Y. Hung, Melissa Bixby, Ira Shoulson, Michael Soileau, James T. Boyd, Peter A LeWitt, Burton L. Scott, Claire Henchcliffe, Patricia Kaminski, Alberto Ascherio, Cornelia Kamp, Lindsay Pothier, Anwar Ahmed, Jill Ciccarello, David J. Houghton, April Langhammer, Rebecca Fitzgerald, Maureen A. Leehey, Anthony E. Lang, Carmen Serrano, Martha McGraw, David Shprecher, Jennifer Durphy, Aleksandar Videnovic, Danish Bhatti, Christine Hunter, Amber Servi Ratel, J. Antonelle de Marcaida, Christopher G. Goetz, Emily Houston, Rajesh Pahwa, Chadwick W. Christine, Gary C. Curhan, Irene Litvan, Christopher A. Beck, Leslie J. Cloud, Patrick Bolger, Karen Thomas, Natividad Stover, Karen Blindauer, Sushrut S. Waikar, and Susan R. Criswell

Subjects
medicine.medical_specialty, business.industry, Dopaminergic, Unified Parkinson's disease rating scale, General Medicine, Placebo, law.invention, Clinical trial, Randomized controlled trial, law, Internal medicine, Severity of illness, medicine, Inosine, business, Adverse effect, medicine.drug, Original Investigation
Abstract

IMPORTANCE: Urate elevation, despite associations with crystallopathic, cardiovascular, and metabolic disorders, has been pursued as a potential disease-modifying strategy for Parkinson disease (PD) based on convergent biological, epidemiological, and clinical data. OBJECTIVE: To determine whether sustained urate-elevating treatment with the urate precursor inosine slows early PD progression. DESIGN, PARTICIPANTS, AND SETTING: Randomized, double-blind, placebo-controlled, phase 3 trial of oral inosine treatment in early PD. A total of 587 individuals consented, and 298 with PD not yet requiring dopaminergic medication, striatal dopamine transporter deficiency, and serum urate below the population median concentration (

Published
2021

2. A Randomized Clinical Trial of High-Dosage Coenzyme Q10 in Early Parkinson Disease

Author

Diane Cote, Jeri Sieren, Alex Rajput, James W. Tetrud, Paul J. Tuite, Christopher T. Ingvoldstad, Cheryl Waters, Shari Niswonger, Roger Kurlan, David D. Song, Jennifer Young, Samuel Markind, Alicia Palao, Munira Sultana, Christine Hunter, Karen Williams, Sandra K. Kostyk, John G. Nutt, Andrew Feigin, Dragos Mihaila, Karen Blindauer, Abraham Lieberman, Annette Robinson, Adrienna Winters, Michelle Cines, Mattson Ogg, Robert A. Hauser, Ira Shoulson, Julia Spears, Jorge L. Juncos, William G. Ondo, David Simon, Mark Stacy, Stacy Merritt, Barbara Shannon, Un Jung Kang, Katie Kompoliti, Cheryl Deeley, Joanne Field, Arthur Watts, Buff Farrow, Karen Helles, Katharine Smith, Karen Thomas, Rajan Prakash, Joel S. Perlmutter, Rajeev Kumar, Mandar Jog, Pamela King, Neal Hermanowicz, Stephen G. Reich, Mark Chilton, Lawrence Severt, Vanessa K. Hinson, Kapil D. Sethi, Mark F. Lew, Pinky Agarwal, Clifford M Shults, Natividad Stover, Richard H. Haas, Jayaraman Rao, Thomas Mayer, Thyagarajan Subramanian, Althea Silver, Richard M. Zweig, Lin Zhang, Hubert H. Fernandez, Linda Cole, Charles H. Adler, Jean Rivest, Marye Kellermann, Marlene Lind, Stephanie Wilson, Jennifer Conway, Ray L. Watts, Monica Beland, Joseph H. Friedman, Michael S. Okun, Maureen Cook, Stephen Grill, Cindy Zadikoff, Irene Litvan, Donna Stuppy Ford, Karen Frei, L Pepper Lumina, David Grimes, Sofya Glazman, Edward Drasby, Wendy R. Galpern, Susan Rolandelli, Sharon Evans, Bernard Ravina, Robert W. Hamill, Jo Bergholte, Andrew Siderowf, W.R. Wayne Martin, Rajesh Pahwa, Sanja Obradov, April Langhammer, Lorelei Derwent, Barbara Sommerfeld, M. Flint Beal, Alok Sahay, Anita Blenke, Liza Reys, Melisa Pelikan, Amy Duffy, Holly A. Shill, Eric Molho, Ivan Bodis-Wollner, Candace Cotto, Marilyn Cowper, Marian L. Evatt, Ani Arkun, Johanna M Hartlein, Nancy Zappala, Clara Schindler Propsom, Matthew Brodsky, Colette Lynn Hilliard, Stephanie Lessig, Stephanie Guthrie, Joanne Wojcieszek, Deborah Fontaine, Irene H. Richard, Zoltan Mari, Kathy Davis, Carlos Singer, Samuel A. Ellias, Lawrence Elmer, Julie So, Louisette Bond, Janis M. Miyasaki, Camille Swartz, Ranjit Ranawaya, Brian Griebner, Ramon L. Rodriguez, Ronald F. Pfeiffer, Becky Dunlop, David Oakes, Michel Panisset, Tiffini Voss, Joohi Jimenez-Shahed, Karyn Boyar, Cathi-Ann Thomas, Victoria Snively, Claire Henchcliffe, Margaret C. Lannon, Maureen Gartner, Cherissa Sia, Maureen A. Leehey, Joan Young, Anwar Ahmed, David S. Russell, Melissa J. Nirenberg, Emmanuelle Pourcher, James T. Boyd, Lauren Kraics, Ted M. Dawson, Ergun Y. Uc, Shan Gao, and Angel Figueroa

Subjects
Male, medicine.medical_specialty, Ubiquinone, Population, Unified Parkinson's disease rating scale, Placebo, Antioxidants, law.invention, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Humans, Prospective Studies, education, Adverse effect, Prospective cohort study, Aged, education.field_of_study, Dose-Response Relationship, Drug, business.industry, Parkinsonism, Parkinson Disease, Middle Aged, medicine.disease, Clinical trial, Early Diagnosis, Treatment Outcome, Physical therapy, Female, Neurology (clinical), business
Abstract

Importance Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit. Objective To examine whether CoQ10 could slow disease progression in early PD. Design, Setting, and Participants A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson’s Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation. Interventions The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E. Main Outcomes and Measures Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo. Results The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo). Conclusions and Relevance Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit. Trial Registration clinicaltrials.gov Identifier:NCT00740714

Published
2014

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