RT info:eu-repo/semantics/article
T1 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
A1 Santos García, Diego
A1 Mir, Pablo
A1 Cubo Delgado, Esther
A1 Vela Desojo, Lydia
A1 Rodríguez Oroz, Mari Cruz
A1 Martí, María José
A1 Arbelo, José Matías
A1 Infante, Jon
A1 Kulisevsky Bojarsky, Jaume
A1 Martínez Martín, Pablo
K1 Biomarkers
K1 Caregiver
K1 Genetic studies
K1 Resonance imaging
K1 Non-motor symptoms
K1 Parkinson’s disease
K1 Progression
K1 Quality of life
K1 Sistema nervioso-Enfermedades
K1 Nervous system-Diseases
K1 Medicina
K1 Medicine
AB BackgroundParkinson’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/designObservational, 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.DiscussionCOPPADIS-2015 is a challenging initiative. This project will provide important information on the natural history of PD and the value of various biomarkers.
PB Springer Nature
YR 2016
FD 2016-02
LK http://hdl.handle.net/10259/8777
UL http://hdl.handle.net/10259/8777
LA eng
NO The project funding is both public and private. There will be an ambitious campaign (COPPADIS Social Project; www.coppadis.com and curemoselparkinson.org) designed to have a huge social impact, developed under a clear and unique concept to engage society.
DS Repositorio Institucional de la Universidad de Burgos
RD 11-may-2024