Format

Send to

Choose Destination
BMC Neurol. 2016 Feb 25;16:26. doi: 10.1186/s12883-016-0548-9.

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.

Collaborators (131)

de Deus Fonticoba T, de Fábregues-Boixar O, Hernández Vara J, Borrue C, Aguilar M, Tijero B, Chacón J, Seijo M, Cabo I, Puente V, Legarda I, Carrillo Padilla F, López Manzanares L, Valero C, Pagonabarraga J, García-Moreno JM, Galeano B, Caballol N, Gastón Zubimendi MI, Sánchez Alonso P, Catalán MJ, López Díaz LM, Alonso Losada MG, López Ariztegui N, Kurtis M, Sierra M, Escalante S, Martínez Castrillo JC, Ribacoba R, González Ardura J, López del Val J, Ávila MA, Alonso-Navarro H, Solano B, García Caldentey J, Rojo A, Martí Martínez S, Domínguez Morán JA, Martínez Torres I, Álvarez Sauco MA, Prieto Jurczynska C, Menéndez González M, Carrillo-García F, Jesús S, Cáceres MT, Oropesa JM, Gómez-Garre MP, Huertas I, Vargas L, Mariscal N, Macías Y, Ruíz Martínez J, Delgado M, Mondragón E, Barandiarán M, Malo R, Planella L, Cámara A, Martí G, Mata M, Pastor P, Quílez P, Badenes D, Casas L, Arribas S, Romero S, Tomé G, Comes L, Guardia G, López J, Gómez Esteban JC, Berganzo K, González A, Acera M, Rodríguez Bóveda I, Álvarez López M, Fernández-Espejo E, Vives B, Pueyo M, de Toledo M, Sobrado M, González García B, Bosca M, Salazar C, Campos A, Pascual B, Damas F, Pacheco E, Merino R, Clavero P, Erró E, Lacruz F, Cabello C, Díez Álvarez M, Montero P, Villanueva C, Meitín T, Murcia S, Clemente J, Sánchez P, González Aramburu I, Esteve P, Reverté S, Alonso A, Avilés I, Suárez E, Sánchez P, Guijarro M, Bellosta E, López García E, Jiménez-Jiménez FJ, Coll C, Montserrat M, Ferriol MM, Leiva C, Hernández L, López Pesquera P, Luca L, Rubio I, Satre I, Freire E, Ordás C, Torres G, Cazorla R, Vengas B, López Seoane B, Faraldo A, Fernández Guillán N, Moreno Diéguez A, Lage Castro M, Vázquez Gómez R.

Author information

1
Sección de Neurología, Complejo Hospitalario Universitario de Ferrol (CHUF), Hospital Arquitecto Marcide, c/Avenida La Residencia, s/n, 15405, Ferrol, Spain. diegosangar@yahoo.es.
2
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.
3
Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Sevilla, Spain. pmir@us.es.
4
Servicio de Neurología, Hospital Universitario de Burgos, Burgos, Spain. esthercubo@gmail.com.
5
Unidad de Neurología, Fundación Hospital de Alcorcón, Madrid, Spain. LVela@fhalcorcon.es.
6
Instituto de Investigación Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain. maria.rodriguezoroz@biodonostia.org.
7
Unidad de Parkinson y Trastornos del Movimiento, Servicio de Neurología, Instituto Clínico de Neurociencias, Hospital Clínic, Barcelona, Spain. MJMarti@clinic.ub.es.
8
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.
9
Unidad de Trastornos del Movimiento, Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander, Spain. jinfante@humv.es.
10
Unidad de Trastornos del Movimiento, Servicio de Neurología, Hospital de Sant Pau, Barcelona, Spain. JKulisevsky@santpau.cat.
11
Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Sevilla, Spain. pmartinez@isciii.es.
12
Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain. pmartinez@isciii.es.

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/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.

PMID:
26911448
PMCID:
PMC4766717
DOI:
10.1186/s12883-016-0548-9
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center