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Table 1 Specific objectives of the COPPADIS-2015 project

From: 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

1)

To study what variables (non-motor symptoms, cognition, neuropsychiatric symptoms, falls, disability, etc.) impact negatively on both overall and health-related QoL of patients with PD.

2)

To study what variables contribute to a worse QoL, mood and the burden of the primary caregiver for the patient with PD, as well as if the latter have repercussions on the mood and QoL of the patient him/herself.

3)

To study the frequency of impulse control disorders and their types in patients with PD, as well as what variables are associated with them and to compare it against a control group.

4)

To study the frequency of different non-motor symptoms in patients with PD and to compare it against a control group.

5)

To study the frequency of pain (and its types) [90] in patients with PD, its relationship to the disease and different variables and to compare it against a control group.

6)

To study the frequency of different types of mood disorders (major depression, minor depression, subclinical depression) [91, 92] in patients with PD, its relationship with other disease variables and to compare it against a control group.

7)

To study the different types of parkinsonian phenotypes [93, 94] and their relationship with other variables (clinical, molecular, genetic and neuroimaging).

8)

To study the relationship between different variables (clinical, molecular, genetic and neuroimaging) and motor laterality asymmetry [95].

9)

To study the relationship between the serum levels of S-100b protein, TNF-ɑ, IL-1, IL-2, IL-6, vitamin B12, methylmalonic acid, homocysteine, uric acid, C-reactive protein, ferritin and iron and other disease variables in patients with PD and to compare it against a control group.

10)

To perform genetic studies on DNA and RNA extracted from the lymphocytes of peripheral blood samples.

11)

To study the possible value of a recently proposed imaging marker (MTAi) [30] to detect cognitive alterations in patients with PD and to compare it against a control group.

12)

To perform volumetric imaging and tractography studies to find correlations, under plausible hypotheses, between the neuroimaging parameters and the clinical or neuropsychiatric variables and/or other variables covered in this study [5961].

13)

To study the incidence of acute hospitalization throughout the 12 months following the baseline assessment (for each patient), their causes, and predictive factors in patients with PD and to compare it against a control group.

14)

To study what percentage of patients with PD develop motor complications (in the subgroup of those who do not present them at the baseline assessment) throughout the 48 months following the baseline assessment (for each patient) and to identify predictive factors.

15)

To study what percentage of patients with PD develop significant cognitive impairment and/or dementia over the course of the 24, 48 and 60 months following the baseline assessment (for each patient), to compare it against a control group and to identify predictive factors (clinical, molecular, genetic, imaging).

16)

To study the morbidity and mortality of patients with PD throughout the 24 and 60 months following the baseline assessment (for each patient), to compare it against a control group and to identify predictive factors (clinical, molecular, genetic, imaging).

17)

At the end of follow-up, to compare the course of the different clinical (motor and no-motor features) and paraclinical variables (molecular and imaging markers).

  1. IL interleukin, PD parkinson’s disease, MTAi, medial temporal atrophy index, QoL quality of life, TNF tumor necrosis factor