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1. Pimavanserin use in a movement disorders clinic: a single-center experience

Author

Patricia Kaminski, Danette Taylor, Bisena Bulica, Abhimanyu Mahajan, Shana Krstevska, Neepa Patel, Ayesha Ahmad, and Peter A LeWitt

Subjects
Male, Psychosis, medicine.medical_specialty, Parkinson's disease, Movement disorders, Pimavanserin, Dermatology, Severity of Illness Index, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Surveys and Questionnaires, Internal medicine, Severity of illness, medicine, Humans, Urea, Dementia, 030212 general & internal medicine, Adverse effect, Aged, Retrospective Studies, Aged, 80 and over, Movement Disorders, business.industry, Parkinsonism, General Medicine, Middle Aged, medicine.disease, Psychiatry and Mental health, Treatment Outcome, chemistry, Female, Neurology (clinical), medicine.symptom, business, Serotonin 5-HT2 Receptor Agonists, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Parkinson’s disease psychosis (PDP) is a disabling non-motor symptom of Parkinson’s disease (PD) that is challenging to treat. Dopamine receptor blockers (DRB) are used to treat PDP, though these may be associated with adverse effects, including worsening of Parkinsonism. Pimavanserin, a selective 5-HT2A receptor inverse agonist, was recently FDA-approved for treatment of PDP; however, there is limited information on its long-term use in PDP patients. A retrospective chart review of patients prescribed pimavanserin was performed in August, 2017. Data on demographics, psychotic features, sleep, and adverse effects was collected using a semi-structured telephone interview with patients or caregivers. Hallucination severity (HS) was quantified as mild (

Published
2018

2. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

William W Busse, Eugene R Bleecker, J Mark FitzGerald, Gary T Ferguson, Peter Barker, Stephanie Sproule, Richard F Olsson, Ubaldo J Martin, Mitchell Goldman, Anahí Yañez, Marcelo Fernández, Alberto Tolcachier, Juan Belloni, Jorge Taborda, Maria De Salvo, Jorge Maspero, Carlos Victorio, Miguel Chirino Navarta, Monica Grilli, Pablo Rodríguez, María Otaola, Víctor Cambursano, Patricia Malamud, Ana Stok, German Arce, Osiris Roza, Fernando Scherbovsky, Pedro Elias, Maria Salazan Saez, Matthew Peters, Martin Phillips, John Upham, Peter Gibson, Francis Thien, Jo Douglass, Paul Thomas, Philip Bardin, Dimitar Sajkov, Mark Hew, David Langton, Andreia Pez, Carlos Fritscher, Jorge Hetzel, Waldo Mattos, Rafael Stelmach, Martti Antila, Ana Luisa Fernandes, Hristo Metev, Yavor Ivanov, Aneliya Bogdanova, Ana Dancheva Markova, Marinka Peneva, Rumyana Veselinova, Tatyana Petkova, Vanushka Petrova, Elena Shopova, Yuliya Ivanova, Rumyana Yotsova, Ginka Kirkova, Galina Petrova, Svetoslav Dachev, Kostadinka Sotirova, Mariyana Stoyanova, Oleg Yakov, Vanya Ilieva-Fartunova, Catherine Lemiere, Michel Laviolette, William Yang, Bonavuth Pek, William Patrick Killorn, Claude Poirier, Guy Chouinard, Lyle Melenka, Richard Leigh, Parameswaran Nair, Delbert Dorscheid, James Martin, Juana Pavie, Andres Rosenblut, Claudia Cartagena, Carlos Quilodran, Silvia Muñoz, Ivana Malkusova, Josef Veverka, Stanislav Holub, Jaroslav Mares, Radovan Kozel, Daniela Kopecka, Vladimir Zindr, Pavel Cerva, Pascal Chanez, Arnaud Bourdin, Gilles Devouassoux, Camille Taille, Frédéric De Blay, Francois Goupil, Christophe Leroyer, Delphine Gourcerol, Toufik Didi, Alain Didier, Gilles Garcia, Philippe Bonniaud, Riazate Rossanaly Vasram, Marek Lommatzsch, Ulf Harnest, Anneliese Linnhoff, Claus Keller, Gerhard Hoheisel, Karin Förster, Thomas Schultz, Isabelle Schenkenberger, Joachim Kirschner, Tibor Schmoller, Stefan Zielen, Marc Kornmann, Ekkehard Beck, Lutz Volgmann, Rolf Dichmann, Axel Overlack, Jörg Winkler, Petra Mikloweit, Sabine Ballenberger, Mathias Rolke, Stephanie Korn, Helmut Pabel, Martin Hoffmann, Jan Feimer, Klaus Rabe, Regina Deckelmann, Tobias Welte, Hiroyuki Ohbayashi, Soichiro Hozawa, Terufumi Shimoda, Makoto Yoshida, Toshikazu Nagakura, Tadashi Kamei, Yasuyuki Sano, Shinichiro Kagami, Hisaho Takahashi, Michiko Haida, Goro Kimura, Hiroyuki Nakamura, Yasuo To, Masaharu Shinkai, Tadasuke Shimokawaji, Makoto Kudo, Noriharu Shijyubo, Takao Tochigi, Motokazu Kato, Akihiko Tanaka, Yasuhiro Gon, Norihisa Sasaki, Tetsuro Ohdaira, Chiharu Omori, Toshiki Takahashi, Satomi Takeuchi, Kiyotaka Nakajima, Hironi Makita, Masahiro Kaneko, Kenjiro Furuta, Masami Taniguchi, Yoshito Inobe, Hiroshi Miki, Yoichi Nakamura, Naoki Miyazawa, Shuichi Yano, Masayuki Iijima, Tsuyoshi Yamato, Javier Diaz, Alberto Matsuno, Efrain Felix, Alfredo Guerreros, Alejandro Daly, Fernando Rodriguez Chariarse, Danilo Salazar, Socorro Castro, William Chavez, Rolando Estrella, Teresita Aquino, Tito Atienza, Ronnie Samoro, Marie Grace Dawn Isidro, Piotr Kuna, Adam Antczak, Michał Bednarek, Danuta Mądra-Rogacka, Teresa Hofman, Marek Jutel, Ewa Pisarczyk-Bogacka, Agata Kot, Robert Mróz, Małgorzata Czupryńska-Borkowska, Małgorzata Żurowska-Gębala, Andrzej Dyczek, Grażyna Jasieniak-Pinis, Piotr Wojnowski, Ewa Trębas-Pietraś, Małgorzata Dobryniewska, Marcin Stobiecki, Marzenna Tarnowska-Matusiak, Alina Magner, Andrzej Kolczyński, Tomasz Kachel, Zbigniew Bartuzi, Bernadetta Majorek-Olechowska, Paweł Śliwiński, Violetta Balicka, Elżbieta Hajoł, Jacek Stachera, Marta Rachel, Marek Michnar, Jarosław Tałałaj, Ewa Springer, Piotr Napora, Tomasz Grzelewski, Renata Bijata-Bronisz, Anna Świderska, Grzegorz Mincewicz, Zbigniew Sankowski, Tomasz Fijołek, Artur Kwaśniewski, Joanna Jerzyńska, Jerzy Cygler, Ryszard Olesiejuk, Iwona Von Steiner, Wojciech Machowiak, Krzysztof Filipek, Piotr Piskorz, Ewa Uhryn, Marita Nittner-Marszalska, Elżbieta Rybicka-Liszewska, Anna Bodzenta-Łukaszyk, Marta Chełmińska, Izabella Krupa-Borek, Wojciech Skucha, Anna Płoszczuk, Traian Mihaescu, Ioan Dorin Petrui, Angelica Savu, Ghiulten Apti, Claudia Toma, Ana Trailescu, Sergei Sokurenko, Vasiliy Trofimov, Igor Leshchenko, Natalia Shaporova, Inna Ilyashevich, Irina Stitsenko, Alexander Vizel, Yulia Ilkovich, Dmitrii Tikhanov, Svetlana Goncharova, Andrey Ezhov, Galina Ignatova, Nadezhda Izmozherova, Nadezhda Berdnikova, Ludmila Goryachkina, Veronika Popova, Laura Bolieva, Andrey Rebrov, Vladimir Nosov, Olga Magnitskaya, Sergey Nedogoda, Vladimir Abrosimov, Artem Molotkov, Galina Reshedko, Mikhail Smirnov, Marina Osipenko, Elena Pavlysh, Svetlana Myasoedova, Liudmila Lenskaya, Valery Chistyakov, Elena Vishneva, Liliya Uon, Anna Zateyschikova, Svetlana Laleko, Tatiana Pak, Axel Bruning, Visvakuren Naidoo, Jeevren Reddy, Richard Van Zyl Smit, Hae-Sim Park, Young Joo Cho, Sang-Heon Cho, Sang Haak Lee, Byung Jae Lee, Ju Sang Kim, You Sook Cho, Choon-Sik Park, Mi-Kyeong Kim, Young-Il Koh, Joo-Hee Kim, Sook Young Lee, Sang Pyo Lee, Jung Won Park, Kwang Ha Yoo, Hyoungkyu Yoon, Jaechun Lee, Gyu-Young Hur, Soo Keol Lee, HeeKyoo Kim, David Ramos Barbón, Elena Laffond Yges, Eva Martínez Moragón, Miguel Arias Guillen, Alberto Saura Vinuesa, Fernando Sánchez-Toril López, José Luis Velasco Garrido, Borja García-Cosio Piqueras, Luis Pérez de Llano, Antonio Luis Valero Santiago, Myriam Calle Rubio, Leif Bjermer, Bo Lundbäck, Bilun Gemicioglu, Sevim Bavbek, Dane Ediger, Munevver Erdinc, Ismail Hanta, Sibel Nayci, Sibel Arinc, Liudmyla Iashyna, Yuriy Mostovoy, Mykola Ostrovskyy, Lesia Kuryk, Ivan Lemko, Tetyana Ospanova, Liubov Moskalenko, Oleksii Korzh, Viktor Blazhko, Olena Krakhmalova, Liliia Romaniuk, Yevgeniya Dytyatkovs'ka, Oleh Yakovenko, Volodymyr Gavrysyuk, Hassan Burhan, Dinesh Saralaya, Stephen Scott, Alyn Morice, Ewart Jackson-Voyzey, Thida Win, Shuab Nasser, Richard Harrison, Rekha Chaudhuri, Monica Nordstrom, Pradip De, Matthew Masoli, Adel Mansur, Anthony Gunstone, Robert Niven, Timothy Harrison, Suresh Babu, Subodh Bhuchar, Shahrukh Kureishy, John Zwetchkenbaum, Lawrence Kaplan, Eugene Bleecker, Santiago Reyes, Faisal Fakih, Marvin Heuer, Ryan Klein, Michael Marcus, Iftikhar Hussain, Tonny Tanus, Hengameh Raissy, Sady Alpizar, Hector Rodriguez, Gerald Gleich, Tracy Bridges, Joe Pouzar, Gary Steven, Jonathan Matz, Shana Krstevska, Dama Ziworitin, Adolfo Kaplan, James Sublett, James DeAngelo, Amy Darter, John Agaiby, John Hagan, Enrique Davis, Dareen Siri, Charlene Mcevoy, Chrisette Dharma, Najmuddin Karimjee, Steven Kelsen, Manuel Frade, Amy Silverthorn, Joel Kline, Francis Averill, Jose Ruiz, Emory Robinette, Zeeshan Shaikh, Carlos Aguilar, William Nish, German Alvarez, Younus Ismail, Purvi Parikh, Mila Leong, Dennis Murphy, Francisco Garcia, Alan Goldsobel, Antonio Blanco, Edward Campbell, Guido Perez, Geoffrey Chupp, Toby Bates, Vandely Perez, Sally Wenzel, Kartik Shenoy, Rohit Katial, David Bernstein, Neil Parikh, William Sims, Gary Ferguson, David Pham, Anu George, Richard Beasley, Gilberto Perez, Robert Garver, Miriam Garcia-Portela, Stephen Wong, Weily Soong, Richard Guillot, Golda Hudes, Ahmed Arif, Josefa Binker, Manuel Villareal, Ulrike Ziegner, Joseph Ojile, Sanjeev Goswami, Carlos Piniella, Ilia Segal, Heidi Zafra, Mitchell Lee, Martha Tarpay, John Panuto, Rajan Merchant, Peter Springsteen, Timothy Scialla, Paul Shapero, Karen Allen, Mark Moss, Humberto Cruz, Jeffrey Rumbyrt, Amy Boyd, Robert Nathan, Jonathan Bernstein, Joshua Jacobs, Elliot Ginchansky, Janice Johnston, Barbara Baxter, Thomas Johnson II, Stephen Apaliski, Clinton Corder, David Fuentes, Joseph Diaz, Chau Ngo, Lan Le, Department of Medicine, University of Wisconsin-Madison-School of Medicine and Public Health, Fundación Cidea Allergy and Respiratory Research Unit, University of Oxford [Oxford], University of Newcastle, Newcastle, NSW Australia., Defence Science and Technology Laboratory (Dstl), Ministry of Defence (UK) (MOD), Organização Multinacional de Formação, Agence Universitaire de la Francophonie (AUF), University of Calgary, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), laboratoire du sommeil, CHU Grenoble, Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Centre Hospitalier du Mans, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Service de pneumologie, Centre hospitalier de la région d'Annecy, Cytokines, chimiokines et immunopathologie, Université Paris-Sud - Paris 11 (UP11)-IFR13-Institut National de la Santé et de la Recherche Médicale (INSERM), J.W. Goethe Universität, Institut für Geowissenschaften, Altenhöferallee 1, D-60438 Frankfurt am Main, Germany, Department of Pulmonary Medicine, Leiden University Medical Center (LUMC), Hannover Medical School [Hannover] (MHH), Japan Energy Corporation, Medical University of Łódź (MUL), Wroclaw Medical University, Saint-Petersburg State University, Physical Department, Petrodvoretz, 194508 St.-Petersburg, Russia, Physical Department (PD), St Petersburg State University (SPbU)-St Petersburg State University (SPbU), Ankara University, Oak Ridge National Laboratory [Oak Ridge] (ORNL), UT-Battelle, LLC, Department of Earth Sciences, University of Cambridge, University of Cambridge [UK] (CAM), Center for Genomics and Personalized Medicine, Wake Forest University, Mayo Clinic [Rochester], Department of Wildlife Management, Pir Mehr Ali Shah Arid Agriculture University, Lab Biotecnol Bacteriana, Inst Ciencia & Tecnol Alimentos & Nutr ICTAN, Universidade da Coruña, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre recherche en CardioVasculaire et Nutrition (C2VN), Université de Brest (UBO), University of Oxford, University of Newcastle [Callaghan, Australia] (UoN), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Universiteit Leiden-Universiteit Leiden, Wrocław Medical University, Department of Earth Sciences [University of Cambridge], and Pir Mehr Ali Shah Arid Agriculture University = PMAS-Arid Agriculture University Rawalpindi (AAUR)

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Adolescent, [SDV]Life Sciences [q-bio], Antibodies, Monoclonal, Humanized, Placebo, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Time, law.invention, Young Adult, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, Clinical endpoint, Humans, Medicine, Anti-Asthmatic Agents, 030212 general & internal medicine, Child, Adverse effect, ComputingMilieux_MISCELLANEOUS, Aged, Asthma, business.industry, Middle Aged, medicine.disease, Benralizumab, 3. Good health, Clinical trial, Treatment Outcome, 030228 respiratory system, Tolerability, chemistry, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that has been shown to safely reduce exacerbations and improve lung function for patients with asthma. We assessed the long-term safety and efficacy of benralizumab for patients with severe, uncontrolled eosinophilic asthma.We conducted a randomised, double-blind, parallel-group, phase 3 extension study at 447 sites in 24 countries. Eligible patients had to have completed the SIROCCO or CALIMA trials and remained on subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W). Patients who had received placebo in those trials were re-randomised in a 1:1 ratio, using an interactive web-based system, to benralizumab 30 mg either Q4W or Q8W (first three doses 4 weeks apart). Treatment lasted for 56 weeks for adult patients (age ≥18 years) and 108 weeks for adolescent patients (age 12-17 years). The primary endpoint was the safety and tolerability of the two dosing regimens of benralizumab up to 68 weeks for adult patients (including the follow-up visit post-treatment) and up to 56 weeks for adolescent patients. This endpoint was assessed in the full analysis set, which included all patients from the SIROCCO and CALIMA predecessor studies who received at least one dose of study treatment in BORA and did not continue into another trial. This study is registered with ClinicalTrials.gov (NCT02258542).Between Nov 19, 2014, and July 6, 2016, we enrolled 1926 patients, of whom 633 had received benralizumab Q4W and 639 had received benralizumab Q8W in SIROCCO or CALIMA. The remaining 654 patients had received placebo in those trials and were randomly re-assigned in this trial to receive benralizumab Q4W (n=320) or Q8W (n=334). 1576 patients, including 783 who received benralizumab Q4W (265 newly assigned) and 793 who received benralizumab Q8W (281 newly assigned), were included in the full analysis set. The most common adverse events in all groups were viral upper respiratory tract infection (14-16%) and worsening asthma (7-10%). The most common serious adverse events were worsening asthma (3-4%), pneumonia (1% to 1%), and pneumonia caused by bacterial infection (0-1%). The percentages of patients who had any on-treatment adverse event, any serious adverse event, or any adverse event leading to treatment discontinuation during BORA were similar between patients originally assigned benralizumab and those originally assigned placebo and between benralizumab treatment regimens. The percentage of patients who had any adverse event was similar between SIROCCO or CALIMA (71-75%; benralizumab group only) and BORA (65-71%), as was the percentage of patients who had an adverse event that led to treatment discontinuation (2% in SIROCCO and CALIMA vs 2-3% in BORA).The 2 years of safety results validate that observations observed in the first year of benralizumab continued through a second year of treatment. No new consequences of long-term eosinophil depletion occurred, and the incidence of other adverse events, including opportunistic infections, were similar during the second year.AstraZeneca and Kyowa Hakko Kirin.

Published
2019

3. Longitudinal study of the substantia nigra in Parkinson disease: A high-field1H-MR spectroscopy imaging study

Author

Jessica Chorostecki, Omar Khan, Carla Santiago, Imad Zak, Shana Krstevska, Edwin George, Fen Bao, Navid Seraji-Bozorgzad, Veronica Gorden, and Christina Caon

Subjects
In vivo magnetic resonance spectroscopy, medicine.medical_specialty, Pathology, Longitudinal study, Parkinson's disease, business.industry, Dopaminergic, Substantia nigra, Disease, Creatine, medicine.disease, Gastroenterology, chemistry.chemical_compound, Neurology, chemistry, Internal medicine, Concomitant, medicine, Neurology (clinical), business
Abstract

Introduction The value of biomarkers in early diagnosis and development of therapeutics in Parkinson's disease (PD) is well established. Methods We used proton magnetic resonance spectroscopy in a prospective, longitudinal study of 23 patients with early PD, naive to dopaminergic therapy, and six age-matched healthy controls to examine the temporal changes in metabolic profile of substantia nigra over a period of 3 months. Results N-acetyl aspartate to creatine ratio at month 3 was compared with baseline values in the PD and control groups, as well as the side-to-side difference of the ratio at baseline. By month 3, n-acetyl aspartate to creatine ratio had decreased by 4.4% in patients with PD (P = 0.024), without a concomitant change in healthy controls. The side-to-side asymmetry was significantly higher in the PD group (16.7%) vs. healthy controls (1.6%, P = 0.0024). Conclusion Estimation of change in the n-acetyl aspartate to creatine ratio appears to be a fast, quantifiable, and reliable marker of dopaminergic neuronal viability in PD. © 2015 International Parkinson and Movement Disorder Society

Published
2015

4. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease

Author

Margaret Marie Cox, Stephanie Sendek, Margaret F. Turk, Julie H. Carter, Susan C. Fagan, Lorelei Derwent, Oksana Suchowersky, Jay S. Schneider, Linda Paul, Gwyn Vernon, Stephen Gollomp, Karl Kieburtz, Debbie Baker, I. Van Bodis-Wollner, Germaine McInnes, Marian A. Perez, G. Webster Ross, Katharine Pabst, Jorge L. Juncos, Chad W. Christine, Jessie Roth, Joseph M. Savitt, Peter A LeWitt, Hubert H. Fernandez, Matthew Brodsky, Mark F. Lew, Jay M. Gorell, Natividad R. Stover, Paulo Guimaraes, Andrew Feigin, Anita Blenke, Martha Nance, Elizabeth Hayes, Andrew Siderowf, W.R. Wayne Martin, Tammie Kelsey, Susan Bennett, Sharon McCarthy, Charles H. Adler, Beverly Olsen, Pauline LeBlanc, Richard B. Dewey, Rodger J. Elble, Richard S. Burns, Carlos Singer, Amy Parsons, John W. Taylor, Tracy Stewart, Maryan DeAngelis, Barbara C. Tilley, William J. Weiner, Brad A. Racette, Wendy R. Galpern, Michael J. Aminoff, Kapil D. Sethi, Jayaraman Rao, Robert A. Hauser, Debbie Fraser, Connie Kawai, David Coffey, Kelly E. Lyons, Kristine Wernette, Becky Dunlop, Holly Delgado, Marlene Lind, Rajesh Pahwa, Chris Weaver, Ray L. Watts, Patricia Deppen, Ryan J. Uitti, Marwan N. Sabbagh, Lynn Marlor, Joann Belden, Burton L. Scott, Theresa McClain, Roger L. Albin, John Y. Fang, Zoran Obradov, Yuko Y. Palesch, Maureen Cook, Pamela Andrews, Jeana Jaglin, Joanne Wojcieszek, Mary Louise Musante Weeks, Susan Peterson, James H. Bower, Maureen A. Leehey, Joanne Field, Lisa M. Shulman, Caroline M. Tanner, Jacob I. Sage, Jordan J. Elm, Joseph Jankovic, Patrick D. Mauldin, Aileen Shinaman, Peng Huang, G. Frederick Wooten, Alicia Brocht, Gordon H. Brown, Peggy Roberge, Dorothy Shearon, Buff Dill, Margaret F. Keller, Charlene Young, Christine Hunter, Janis M. Miyasaki, Susan Torgrimson, Cornelia Kamp, Brigid Hayward, Christopher G. Goetz, Emily Kosa, Marilyn Flewellen, David Simon, Rebecca McMurray, Sue Reichwein, Jacci Bainbridge, Robert W. Hamill, Stephanie Terashita, Kathleen M. Shannon, Frederick Wooten, Danna Jennings, Shana Krstevska, and Bernard Ravina

Subjects
Male, medicine.medical_specialty, Future studies, Neurology, Ubiquinone, Coenzymes, Disease, Placebo, Tacrolimus, law.invention, chemistry.chemical_compound, Double-Blind Method, Randomized controlled trial, law, Rating scale, Internal medicine, Humans, Medicine, Aged, Coenzyme Q10, business.industry, Headache, Nausea, Parkinson Disease, Middle Aged, Clinical trial, chemistry, Physical therapy, Female, Neurology (clinical), business
Abstract

Objective: To determine if future studies of coenzyme Q10 and GPI-1485 in Parkinson disease (PD) may be warranted. Methods: We conducted a randomized, double-blind, calibrated futility clinical trial of coenzyme Q10 and GPI-1485 in early untreated PD using placebo data from the DATATOP study to establish the futility threshold. Results: The primary outcome measure (change in total Unified Parkinson's Disease Rating Scale scores over 1 year) did not meet the prespecified criteria for futility for either agent. Secondary analyses using calibration controls and other more recent placebo data question the appropriateness of the predetermined definition of futility, and suggest that a more restrictive threshold may be needed. Conclusions: Coenzyme Q10 and GPI-1485 may warrant further study in Parkinson disease, although the data are inconsistent. Additional factors (cost, availability of other agents, more recent data on placebo outcomes, other ongoing trials) should also be considered in the selection of agents for Phase III studies. NEUROLOGY 2007;68:20-28

Published
2007

5. Longitudinal study of the substantia nigra in Parkinson disease: A high-field (1) H-MR spectroscopy imaging study

Author

Navid, Seraji-Bozorgzad, Fen, Bao, Edwin, George, Shana, Krstevska, Veronica, Gorden, Jessica, Chorostecki, Carla, Santiago, Imad, Zak, Christina, Caon, and Omar, Khan

Subjects
Male, Substantia Nigra, Aspartic Acid, Proton Magnetic Resonance Spectroscopy, Humans, Female, Parkinson Disease, Longitudinal Studies, Middle Aged, Creatine, Biomarkers, Article, Aged
Abstract

The value of biomarkers in early diagnosis and development of therapeutics in Parkinson's disease (PD) is well established.We used proton magnetic resonance spectroscopy in a prospective, longitudinal study of 23 patients with early PD, naïve to dopaminergic therapy, and six age-matched healthy controls to examine the temporal changes in metabolic profile of substantia nigra over a period of 3 months.N-acetyl aspartate to creatine ratio at month 3 was compared with baseline values in the PD and control groups, as well as the side-to-side difference of the ratio at baseline. By month 3, n-acetyl aspartate to creatine ratio had decreased by 4.4% in patients with PD (P = 0.024), without a concomitant change in healthy controls. The side-to-side asymmetry was significantly higher in the PD group (16.7%) vs. healthy controls (1.6%, P = 0.0024).Estimation of change in the n-acetyl aspartate to creatine ratio appears to be a fast, quantifiable, and reliable marker of dopaminergic neuronal viability in PD.

Published
2014

6. Successful Vim targeting for mixed essential and parkinsonian tremor using intraoperative MRI

Author

Christos Sidiropoulos, Shana Krstevska, Jason M. Schwalb, and Lynn Mubita

Subjects
Deep brain stimulation, Essential tremor, business.industry, medicine.medical_treatment, Thalamus, Ventral Thalamic Nucleus, medicine.disease, Intraoperative MRI, Neurology, Anesthesia, Medicine, Neurology (clinical), business, Intraoperative neurophysiological monitoring
Published
2015

7. The reliability of the diagnostic features in patients with narcolepsy

Author

Michael Folkerts, Shana Krstevska, Robert Wittig, Frank Zorick, Leon Rosenthal, Thomas Roth, Anjana Murlidhar, and Timothy Roehrs

Subjects
Adult, Male, Multiple Sleep Latency Test, Pediatrics, medicine.medical_specialty, Adolescent, Cataplexy, Polysomnography, Sleep, REM, Excessive daytime sleepiness, Neurological disorder, medicine, Humans, Age of Onset, Child, Biological Psychiatry, Aged, Narcolepsy, Sleep disorder, medicine.diagnostic_test, Reproducibility of Results, Middle Aged, medicine.disease, Anesthesia, Female, Age of onset, medicine.symptom, Psychology
Abstract

This study determined the test-retest reliability of the polysomnographic findings in narcolepsy. The diagnosis of narcolepsy was based on clinical symptoms and polysomnographic signs. Control subjects were screened before participation and were split based on their screening multiple sleep latency test (MSLT) into high- and low-MSLT groups. Subjects completed two polysomnographic evaluations with at least 5 days between laboratory tests. Narcoleptics had lower sleep efficiencies and high stage 1% when compared to the low MSLT control group. They had more awakenings and less stage 2% than the control groups. Narcoleptics had a shorter latency to 1 when compared to the high-MSLT group but comparable to that of the low-MSLT group. Narcoleptics had a higher number of sleep-onset rapid eye movement periods (SOREMPs) than both control groups. The MSLT scores were stable across the two evaluations and showed a statistically significant correlation. Twenty-eight of the 30 narcoleptic subjects had two or more SOREMPs on reevaluation. None of the controls had multiple SOREMPs. Thus, multiple SOREMPs were shown to be a reliable finding in patients with narcolepsy.

Published
1996

8. Auditory awakening thresholds in sleepy and alert individuals

Author

Thomas Roth, Todd Helmus, Christopher Bishop, Timothy Roehrs, Shana Krstevska, and Leon Rosenthal

Subjects
Multiple Sleep Latency Test, Adult, Male, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, media_common.quotation_subject, Polysomnography, Significant group, Sleep, REM, Audiology, Non-rapid eye movement sleep, Developmental psychology, Auditory stimulation, Physiology (medical), medicine, Humans, Wakefulness, media_common, medicine.diagnostic_test, Electromyography, Sleep deprivation, Electrooculography, Acoustic Stimulation, Sleep Deprivation, Female, Neurology (clinical), Sleep Stages, medicine.symptom, Psychology, Somnolence, Vigilance (psychology)
Abstract

Twenty-seven healthy men and women with regular sleep-wake habits (and no habitual napping) participated in a study to determine the relation between auditory awakening thresholds (AAT) and multiple sleep latency test (MSLT) scores. Subjects were free of any sleep complaints and were screened polysomnographically. Nine subjects had a screening MSLT ofor = 5 minutes (sleepy group), and 18 subjects had an MSLT ofor = 10 minutes. Subjects were assigned to three groups: a sleepy group, alert group and an alert sleep-deprived group. Subjects underwent 2 nights of AAT testing with at least 5 days in between each study night. AATs were determined at 0100, 0300, 0500 and 0730 hours. There were a total of 209 available AAT determinations, with a comparable number of trials across the groups. Because 68% of AAT determinations were done out of stage 2 non-rapid eye movement (NREM) sleep, the thrust of the analysis was based on the results of this stage of sleep. The AATs were averaged across the two experimental nights. Trials 1 and 2 (first half of the night) and 3 and 4 (second half of the night) were averaged for each subject. There was no main effect of group on AATs. However, there was a significant main effect of time and a significant group by time interaction. The former indicated an overall decline in AATs across the night. More importantly, the three groups had comparable AAT levels during the first half of the night:. Sleepy and alert-deprived subjects, however, failed to show a decline in AATs, whereas the alert group showed a significant decline in the second half of the night. This differential rate of decline in AATs is suggested to be related to the differences in sleep homeostasis among alert and sleepy individuals.

Published
1996

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