Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | |||
---|---|---|---|---|---|---|---|---|---|---|
Assessment | Screening | Baseline | Week 2 | Week 4 | Week 6 | Week 13 | Week 26 | Week 39 | Week 52 | Week 104 |
Informed consent | x | |||||||||
Inclusion and exclusion criteria review | x | x | ||||||||
Patient demographics | x | |||||||||
Vital signs | x | x | x | x | x | x | x | |||
Informant demographics | x | |||||||||
Patient clinical and medical history | x | |||||||||
Physical examination | x | x | x | |||||||
Neurological assessment | x | x | x | |||||||
Previous medications | x | |||||||||
Current medications | x | x | x | x | x | x | x | |||
Co-morbidities | x | |||||||||
Biochemistry profile | x | x | x | x | ||||||
Full blood count | x | x | x | x | ||||||
ECG | x | x | x | x | ||||||
MRI | x | x | ||||||||
Telephone follow-up | x | x | ||||||||
Cognitive assessments | ||||||||||
VADAS-cog | x | x | x | x | x | x | ||||
CGIC | x | x | x | x | ||||||
sMMSE | x | x | x | x | x | |||||
Trail Making B | x | x | x | x | ||||||
TICS-M | x | x | x | x | ||||||
Informant/Patient Questionnaires | ||||||||||
EQ-5D | x | x | x | x | ||||||
DAD (informant) | x | x | x | x | ||||||
GHQ12 (informant) | x | x | x | x | ||||||
EQ-5D (informant) | x | x | x | x | ||||||
DEMQOL (informant) | x | x | x | x | ||||||
NPI-D (informant) | x | x | x | x | ||||||
CSRI (informant) | x | x | x | x | ||||||
Service use log | x | x | x | |||||||
Advice sheet | x | |||||||||
Adverse events | x | x | x | x | x | x | x | |||
Study drug dispensing | x | x | x | x |