Table 2.
NorAD trial schedule of visits
| 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 |
There is a ± 3-day window for each assessment
ADAS-Cog Alzheimer’s Disease Assessment Scale-Cognitive Subscale, ADCS-ADL Alzheimer’s Disease Co-operative Study - Activities of Daily Living Inventory, AE/CM adverse event/concomitant medication, CANTAB-RVP Cambridge Neuropsychological Automated Battery-Rapid Visual Information Processing, ChEI cholinesterase inhibitor, ECG electrocardiogram, ESS Epworth Sleepiness Scale, HR heart rate, LFT liver function test, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, s/s BP sitting and standing blood pressure, SEQ Side-Effect Questionnaire, TEA Test of Attention, U&E urea and electrolytes, W Week, ZBI Zarit Burden Interview