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dc.contributor.authorSantos-García, Diego
dc.contributor.authorMir, Pablo
dc.contributor.authorCubo, Esther
dc.contributor.authorVela, Lydia
dc.contributor.authorRodríguez-Oroz, Mari Cruz
dc.contributor.authorMartí, Maria José
dc.contributor.authorArbelo, José Matías
dc.contributor.authorInfante, Jon
dc.contributor.authorKulisevsky, Jaime
dc.contributor.authorMartinez-Martin, Pablo 
dc.date.accessioned2017-09-04T16:28:32Z
dc.date.available2017-09-04T16:28:32Z
dc.date.issued2016-02-25
dc.identifier.citationBMC Neurol. 2016; 16: 26
dc.identifier.urihttp://hdl.handle.net/20.500.12105/4813
dc.description.abstractBACKGROUND: 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/DESIGN: 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. STUDY POPULATION: 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. FUNDING: Public/Private. DISCUSSION: COPPADIS-2015 is a challenging initiative. This project will provide important information on the natural history of PD and the value of various biomarkers.
dc.description.sponsorshipABBVIE, ACEBRE, ALTER, ASOCIACIÓN PARKINSON ARAGON, ASOCIACIÓN PARKINSON PALENCIA, ASOCIACIÓN PARKINSON VALENCIA, AYUNTAMIENTO DE A CORUÑA, CLIMANOSA, CONSTRUDECO NORTE, FEDERACION GALLEGA ATLETISMO, ESTEVE, LUNDBECK, QUALIGEN, UCB PHARMA, VALENCIA CONCIERGE, VIAJES GALITUR, ZAMBON and many individual donors.
dc.language.isoeng
dc.publisherBioMed Central
dc.relation.isversionofPublisher's version
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectBiomarkers
dc.subjectCaregiver
dc.subjectGenetic studies
dc.subjectMagnetic resonance imaging
dc.subjectNon-motor symptoms
dc.subjectParkinson’s disease
dc.subjectProgression
dc.subjectQuality of life
dc.titleCOPPADIS-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
dc.typeArtículo
dc.rights.licenseAtribución 4.0 Internacional*
dc.identifier.pubmedID26911448
dc.format.volume16
dc.format.number1
dc.format.page26
dc.identifier.doi10.1186/s12883-016-0548-9
dc.contributor.funderThe project funding is both public and private. There will be an ambitious campaign (COPPADIS Social Project
dc.description.peerreviewed
dc.identifier.e-issn1471-2377
dc.relation.publisherversionhttps://doi.org/10.1186/s12883-016-0548-9
dc.identifier.journalBMC Neurology
dc.repisalud.centroISCIII::Centro Nacional de Epidemología
dc.repisalud.institucionISCIII
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses_ES


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