|
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
| | |
- ECG electrocardiograph, MRI magnetic resonance imaging, VADAS-cog vascular dementia assessment scale cognitive subscale, CGIC clinical global impression of change, sMMSE standardised Mini-Mental State Examination, TIC-M modified telephone interview for cognitive status, EQ-5D EuroQol group 5 dimensions health questionnaire, DAD disability assessment in dementia, GHQ12 12-item general health questionnaire, DEMQOL dementia quality of life, NPI-D neuropsychiatric inventory caregiver distress, CSRI client service receipt inventory
