Table 1.
Before randomisation | Intervention period (1–24 weeks after randomisation) |
Follow-up period (25–36 weeks after randomisation) | After randomisation | ||
---|---|---|---|---|---|
Item | − 2 to −1 week | 9 weeks | 17 weeks | 25 weeks | 37 weeks |
Eligible assessment | |||||
Diagnostic criteria | × | ||||
Inclusion criteria | × | ||||
Exclusion criteria | × | ||||
Baseline measurement | × | ||||
Primary outcomes | |||||
Global cognitive function | × | × | × | × | × |
Secondary outcomes | |||||
Memory | × | × | × | × | × |
Attention | × | × | × | × | × |
Processing speed | × | × | × | × | × |
Execution | × | × | × | × | × |
Verbal learning and memory | × | × | × | × | × |
Structure and function of related brain regions | × | × | × | ||
Cerebrovascular function | × | × | × | ||
Quality of life | × | × | × | ||
Adverse events | × |
The×indicates at which point of the trial the respective assessments will take place.