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-?, 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.
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