Table 1 Data collection and procedures per study visit.
Visit | V0 | V1 | V2 | V3 | V4 | V5 (FU) |
|---|---|---|---|---|---|---|
Months from the baseline | 0 | 6 | 12 | 18 | 24 | 25 |
Procedure | ||||||
Informed consent | X | X | ||||
Eligibility | X | |||||
Medical history | X | |||||
Vital signs and weight | X | X | X | |||
Anthropometric study (Tanita) | X | X | X | |||
Neurological examination | X | X | X | X | ||
Adverse events | X | X | X | X | X | |
Concomitant medication | X | X | X | X | X | X |
Medication dispensing | X | X | X | X | ||
Medication adherence questionnaire | X | X | X | X | ||
Assessment | ||||||
Blood drawn and plasma obtention | X | X | X | X | X | X |
Mini-Mental State Examination (MMSE)* | X | X | X | |||
Clinical dementia rating (CDR) | X | X | X | |||
Hachinski Ischemic Scale | X | X | X | |||
Neuropsychiatric Inventory Questionnaire (NPI)* | X | X | X | |||
Global Deterioration Scale (GDS) | X | X | X | |||
Geriatric Depression Scale | X | X | X | |||
Blessed Scale | X | X | X | |||
NBACE** | X | X | X | |||
HADS*** | X | X | X | |||