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| Título: | 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 |
Autor: | Santos-García, Diego; Mir, Pablo CSIC ORCID; Martínez-Martín, Pablo; Arribas-Mocoroa, Santiago CSIC ORCID | Fecha de publicación: | 25-feb-2016 | Editor: | BioMed Central | Citación: | BMC Neurology 16: 26 (2016) | Resumen: | [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/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. |
Descripción: | Santos-García, Diego et al.-- COPPADIS Study Group | Versión del editor: | http://doi.org/10.1186/s12883-016-0548-9 | URI: | http://hdl.handle.net/10261/143633 | DOI: | 10.1186/s12883-016-0548-9 | Identificadores: | issn: 1471-2377 | Referencias: | Santos-García, Diego et al. Erratum to: 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. https://doi.org/10.1186/s12883-016-0567-6 . http://hdl.handle.net/10261/143660 |
| Aparece en las colecciones: | (IBIS) Artículos |
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| COPPADIS_2015_Santos.pdf | 2,29 MB | Adobe PDF |  Visualizar/Abrir |
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