title: COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015), a global--clinical evaluations, serum biomarkers, genetic studies and neuroimaging--prospective, multicenter, non-interventional, long-term study on Parkinson's disease progression.
abstract: BACKGROUND
  Parkinson's disease (PD) is a progressive neurodegenerative disorder causing motor and non-motor symptoms that can affect independence, social adjustment and the quality of life (QoL) of both patients and caregivers. Studies designed to find diagnostic and/or progression biomarkers of PD are needed. We describe here the study protocol of COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015), an integral PD project based on four aspects/concepts: 1) PD as a global disease (motor and non-motor symptoms); 2) QoL and caregiver issues; 3) Biomarkers; 4) Disease progression.
  
  
  METHODS
  Observational, descriptive, non-interventional, 5-year follow-up, national (Spain), multicenter (45 centers from 15 autonomous communities), evaluation study. Specific goals: (1) detailed study (clinical evaluations, serum biomarkers, genetic studies and neuroimaging) of a population of PD patients from different areas of Spain, (2) comparison with a control group and (3) follow-up for 5 years. COPPADIS-2015 has been specifically designed to assess 17 proposed objectives.
  
  
  METHODS
  approximately 800 non-dementia PD patients, 600 principal caregivers and 400 control subjects. Study evaluations: (1) baseline includes motor assessment (e.g., Unified Parkinson's Disease Rating Scale part III), non-motor symptoms (e.g., Non-Motor Symptoms Scale), cognition (e.g., Parkinson's Disease Cognitive Rating Scale), mood and neuropsychiatric symptoms (e.g., Neuropsychiatric Inventory), disability, QoL (e.g., 39-item Parkinson's disease Quality of Life Questionnaire Summary-Index) and caregiver status (e.g., Zarit Caregiver Burden Inventory); (2) follow-up includes annual (patients) or biannual (caregivers and controls) evaluations. Serum biomarkers (S-100b protein, TNF-α, IL-1, IL-2, IL-6, vitamin B12, methylmalonic acid, homocysteine, uric acid, C-reactive protein, ferritin, iron) and brain MRI (volumetry, tractography and MTAi [Medial Temporal Atrophy Index]), at baseline and at the end of follow-up, and genetic studies (DNA and RNA) at baseline will be performed in a subgroup of subjects (300 PD patients and 100 control subjects). Study periods: (1) recruitment period, from November, 2015 to February, 2017 (basal assessment); (2) follow-up period, 5 years; (3) closing date of clinical follow-up, May, 2022.
  
  
  BACKGROUND
  Public/Private.
  
  
  CONCLUSIONS
  COPPADIS-2015 is a challenging initiative. This project will provide important information on the natural history of PD and the value of various biomarkers.
authors.affiliation: Sección de Neurología, Complejo Hospitalario Universitario de Ferrol (CHUF), Hospital Arquitecto Marcide, c/Avenida La Residencia, s/n, 15405, Ferrol, Spain. diegosangar@yahoo.es.
authors.forename: Diego
authors.initials: D
authors.lastname: Santos-García
authors.affiliation: Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, CSIC y Universidad de Sevilla, Sevilla, Spain. pmir@us.es.|Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Sevilla, Spain. pmir@us.es.
authors.forename: Pablo
authors.initials: P
authors.lastname: Mir
authors.affiliation: Servicio de Neurología, Hospital Universitario de Burgos, Burgos, Spain. esthercubo@gmail.com.
authors.forename: Esther
authors.initials: E
authors.lastname: Cubo
authors.affiliation: Unidad de Neurología, Fundación Hospital de Alcorcón, Madrid, Spain. LVela@fhalcorcon.es.
authors.forename: Lydia
authors.initials: L
authors.lastname: Vela
authors.affiliation: Instituto de Investigación Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain. maria.rodriguezoroz@biodonostia.org.
authors.forename: Mari Cruz
authors.initials: MC
authors.lastname: Rodríguez-Oroz
authors.affiliation: Unidad de Parkinson y Trastornos del Movimiento, Servicio de Neurología, Instituto Clínico de Neurociencias, Hospital Clínic, Barcelona, Spain. MJMarti@clinic.ub.es.
authors.forename: Maria José
authors.initials: MJ
authors.lastname: Martí
authors.affiliation: Unidad de Trastornos del Movimiento y enfermedad de Parkinson, Servicio de Neurología, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain. jmarbelo@gmail.com.
authors.forename: José Matías
authors.initials: JM
authors.lastname: Arbelo
authors.affiliation: Unidad de Trastornos del Movimiento, Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander, Spain. jinfante@humv.es.
authors.forename: Jon
authors.initials: J
authors.lastname: Infante
authors.affiliation: Unidad de Trastornos del Movimiento, Servicio de Neurología, Hospital de Sant Pau, Barcelona, Spain. JKulisevsky@santpau.cat.
authors.forename: Jaime
authors.initials: J
authors.lastname: Kulisevsky
authors.affiliation: Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Sevilla, Spain. pmartinez@isciii.es.|Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain. pmartinez@isciii.es.
authors.forename: Pablo
authors.initials: P
authors.lastname: Martínez-Martín
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D017028:Caregivers / Q000523:psychology*; D006233:Persons with Disabilities; D018450:Disease Progression; D006801:Humans; D059906:Neuroimaging / Q000379:methods; D010300:Parkinson Disease / Q000503:physiopathology* / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life; D013030:Spain; D011795:Surveys and Questionnaires
chemical_list: D015415:Biomarkers