2026-08-25T14:09:12Zhttps://repisalud.isciii.es/rest/oai/request
oai:repisalud.isciii.es:20.500.12105/48132024-11-28T16:47:29Zcom_20.500.12105_2052com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19608col_20.500.12105_16958col_20.500.12105_16974
Repisalud author Santos-García, Diego author Mir, Pablo author Cubo, Esther author Vela, Lydia author Rodríguez-Oroz, Mari Cruz author Martí, Maria José author Arbelo, José Matías author Infante, Jon author Kulisevsky, Jaime author Martínez-Martín, Pablo funder AbbVie funder Acebre funder Alter funder Asociación parkinson Aragón funder Asociación parkinson Palencia funder Asociación parkinson Valencia funder Ayuntamiento de A Coruña (España) funder Climanosa funder Construdeco norte funder Federación gallega atletismo funder Esteve (España) funder Lundbeck Foundation funder Qualigen funder UCB Pharma funder Generalitat Valenciana (España) funder Viajes galitur funder Zambon 2017-09-04T16:28:32Z 2017-09-04T16:28:32Z 2016-02-25 BMC Neurol. 2016; 16: 26 10.1186/s12883-016-0548-9 1471-2377 BMC Neurology 26911448 http://hdl.handle.net/20.500.12105/4813 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. 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. eng Biomarkers Caregiver Genetic studies Magnetic resonance imaging Non-motor symptoms Parkinson’s disease Progression Quality of life 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 journal article URL https://repisalud.isciii.es/bitstreams/060ef366-2109-431e-9d19-4e84a85570d8/download File MD5 6fbfa593029d2245c329d6566fab974d 2343437 application/pdf COPPADIS2015COhortOf_2016.pdf URL https://repisalud.isciii.es/bitstreams/66c9b1a3-38dc-42e7-88ae-6af01b8944f0/download File MD5 0e28add2ee1e99fe8da60c20a5f869df 370437 application/pdf ErratumToCOPPADIS2015_2016.pdf URL https://repisalud.isciii.es/bitstreams/c52f7bc2-512e-4e9c-8b08-33c41c0b9542/download File MD5 42dafb998773fc2ef9c5acab05b4d791 75152 text/plain 12883_2016_Article_548.pdf.txt URL https://repisalud.isciii.es/bitstreams/b7434551-58ad-47c3-869d-d923034fe2d5/download File MD5 42dafb998773fc2ef9c5acab05b4d791 75152 text/plain 12883_2016_Article_548.pdf.txt URL https://repisalud.isciii.es/bitstreams/87bdd9fa-6222-4f4c-aa6b-cf5c5896cce1/download File MD5 42dafb998773fc2ef9c5acab05b4d791 75152 text/plain COPPADIS2015COhortOf_2016.pdf.txt URL https://repisalud.isciii.es/bitstreams/269d0724-27c4-430d-88e8-098b5485e8f5/download File MD5 42dafb998773fc2ef9c5acab05b4d791 75152 text/plain COPPADIS2015COhortOf_2016.pdf.txt URL https://repisalud.isciii.es/bitstreams/216e69b9-2c7b-470e-a63f-5289d4b01ac7/download File MD5 752631cc4f864790f7c77d74f30de775 11529 text/plain ErratumToCOPPADIS2015_2016.pdf.txt