Related to eficacy
1. UPDRS motor. measure by UPDRS III. Measuring time: 0, 6, 9 months
2. Daytime mobility fluctuations: measured by self-report. Measure by: Presence of on/off (on and off) dyskinesias (yes/no), dystonias (score), paradoxical fluctuations (score). Measuring time: 0, 6, 9 months
3. Total dose of dopaminergic stimulation. Measure by percentage. Measuring time: in each administration of the product.
4. Cognitive impairment. Measured by the DRS (Dementia Rating Scale) by Mattis. Measuring time:: 0, 9 months
5. Mental flexibility. Measured by the Trail Test (TMT). Measuring time: 0, 9 months
6. Working Memory. Measured by the TMT. Measuring time: 0, 9 months
7. Motor response rate. Measured by the TMT. Measuring time: 0, 9 months
8. Sustained attention. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months
9. Working memory. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months
10. Phonological verbal fluency. Measured by the Verbal Fluency Test (FAST). Measuring time: 0, 9 months
11. Semantic verbal fluency. Measured by FAST. Measuring time: 0, 9 months
12. Ability to alternate mental categories. Measured by FAST. Measuring time: 0, 9 months
13. Executive function. Measured by Litvan Frontal Assessment Battery (FAB). Measuring time: 0, 9 months
14. Selective attention (Measured by Stroop test). Measuring time:: 0, 9 months
15. Focused attention (Measured by Stroop test). Measuring time: 0, 9 months
16. Visuoconstructive function (Measured by Fig. De Rey). Measuring time: 0, 9 months
17. Visual memory (Measured by Fig. Of Rey). Measuring time:: 0, 9 months
18. Level of anxiety. Measured by the HADS (Hospital Anxiety and Depression Scale) Hospital Anxiety and Depression Scale. Measuring time: 0, 9 months
19. Level of depression. Measured by HADS. Measuring time: 0, 9 months
Related to safety:
20. Adverse Events-AE (Severity of AE (serious or not), Type of AE (accordint to Regulation 45/2007 CECMED), Intensity of AE (mild, moderate, serious), Causality relationship (Very likely, Likely, possible, unlikely, unrelated or non-evaluable), Attitude about the drug (No change, dose reduction, temporary interruption of treatment, definitive discontinuation of treatment), Outcome (Reversible effect, irreversible effect, death, loss of patient follow-up)). Measuring time: in each evaluation at 6 and 9 months and in each administration of the product.
21. Laboratory test (Hemoglobin (Normal, abnormal), Hematocrit (Normal, abnormal), Platelet count (Normal, abnormal), Leukocyte count (Normal, abnormal), Glycemia (Normal, abnormal), TGO (Normal, abnormal), TGP (Normal, abnormal), GGT (Normal, abnormal), Creatinine, (Normal, abnormal), uric acid (Normal, abnormal), urea (normal, abnormal)). Measuring time: 0, 6 and 9 months.
22. Blood pressure (mm/Hg). Measuring time: in each evaluation at 0, 6 and 9 months and in each administration of the product.