Items | −2 weeks (run-in) | 0 week (baseline) | 12 weeks (mid-term follow-up) | 24 weeks (endpoint) | 36 weeks (follow-up) |
---|---|---|---|---|---|
Inclusion criteria | √ | ||||
Exclusion criteria | √ | ||||
MRI scan | √ | ||||
Informed consent | √ | ||||
General information | √ | ||||
Vital signs | √ | √ | √ | √ | √ |
MMSE | √ | √ | √ | √ | √ |
HAMD | √ | ||||
HIS | √ | ||||
ADAS-cog | √ | √ | √ | √ | |
CIBIS | √ | ||||
CIBIC-plus | √ | √ | √ | ||
ADL | √ | √ | √ | √ | |
Safety measure | √ | √ | √ | ||
Adverse event | √ | √ | √ | ||
Concomitant drugs | √ | √ | √ | √ |