Procedures (following pre-screening visit) | Screening visit | 0 (W0) | 1 (W1) | 2 (T/C) (W2) | 3 (W4) | 4 (W8) | 5 (W12) | 6 (T/C) (W13) |
---|---|---|---|---|---|---|---|---|
MMSE | X | X | X | |||||
ECG | X | X | X | |||||
U&E, LFT | X | |||||||
HR, s/s BP | X | X | X | X | X | X | ||
≥ 3 months treatment with ChEI | X | X | ||||||
Consent | X | X | ||||||
Medical history | X | |||||||
Inclusion/exclusion | X | X | ||||||
Randomisation | X | |||||||
ADAS-Cog | X | X | X | |||||
Trails A and B | X | X | X | |||||
Digit-symbol substitution | X | X | X | |||||
TEA (map search and elevator counting) | X | X | X | |||||
CANTAB-RVP | X | X | X | |||||
NPI | X | X | X | |||||
ZBI | X | X | X | |||||
ADCS-ADL | X | X | X | |||||
ESS | X | X | X | X | X | |||
SEQ | X | X | X | X | X | X | ||
AE/CM | X | X | X | X | X | X | ||
Unused dose counts | X | X | X | X | ||||
Dispensing | X | X | X | X |