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

Santos-García, Diego et al.-- COPPADIS Study Group
[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.
Diego Santos-García has received honoraria for educational presentations by Abbvie, UCB Pharma and Lundbeck. Pablo Mir has received honoraria for lecturing or advisory boards from AbbVie, UCB, Zambon, Allergan and Merz, and research grants from the Ministerio de Economía y Competitividad de España [SAF2007-60700], the Instituto de Salud Carlos III [PI10/01674, CP08/00174, PI13/01461], the Consejería de Economía, Innovación, Ciencia y Empleo de la Junta de Andalucía [CVI-02526, CTS-7685], the Consejería de Salud y Bienestar Social de la Junta de Andalucía [PI-0377/2007, PI-0741/2010, PI-0437-2012], the Sociedad Andaluza de Neurología, the Jacques and Gloria Gossweiler Foundation and the Fundación Alicia Koplowitz. Esther Cubo has received travel funding from Abbvie, Allergan and UCB Pharmaceuticals, and received research support from the Movement Disorder Society, World Federation of Neurology and Junta de Castilla y León. Lydia Vela has received honoraria for educational presentations by Abbvie, UCB Pharma and Lundbeck. Maria C Rodriguez-Oroz has received payment for lectures, travel and accommodation to attend scientific meetings from UCB, Lundbeck, Abbvie and Boston Scientific. She has received grants from CIBERNED, Government of Basque Country and Guipuzcoa, Spanish Health Institute and Era-net. Maria J Marti has received speaking fees from Ipsen, Merz, Allergan and UCB Pharma and research grants from Ministery of Health and Social Services, Marató TV3, Centro Investigacion Biomedica en Red and Michael J Fox Foundation for Parkinson’s research. Jose M Arbelo has received honoraria for educational presentations or clinical studies participation by Abbvie, UCB Pharma and Italfarmaco. Jon Infante has received honoraria as a speaker from UCB Pharma and traveling grants from Abbvie. Jaime Kulisevsky has received honoraria for lecturing or advisoring from Abbvie, UCB and Zambon. Pablo Martínez-Martin has received honorarium from Abbvie for a symposium and participation in the Advisory Board for an epidemiological study, Editorial Viguera for a master course, UCB for lecturing in International University Menendez Pelayo summer course.Santos-García