Table 1.
Schedule of study visits.*
| Baseline | Treatment period | P/w | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Week number | −3 | −2 | −1 | 0 | 2 | 4 | 6 | 8 | 10 |
| Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Review records | X | ||||||||
| Explain study | X | ||||||||
| Obtain consent | X | ||||||||
| Patient registration | X | ||||||||
| Demographics | X | ||||||||
| Electrocardiogram | X | X | |||||||
| Physical examination | X | X | |||||||
| Pill count/dispense | X | X | X | X | X | ||||
| Adverse events | X | X | X | X | X | X | |||
| Vital signs | X | X | X | X | X | X | X | ||
| Concurrent medications | X | X | X | X | X | X | X | X | X |
| Laboratory studies/melatonin | X | X | |||||||
| MMSE | X | X | |||||||
| ADAS-cog | X | ||||||||
| Hamilton Depression Rating Scale | X | X | X | ||||||
| Sleep Disorders Inventory | X | X | X | X | X | X | X | ||
| NPI | X | X | X | X | |||||
| ADCS-ADL | X | X | X | X | |||||
| Actigraph procedures | X | X | X | X | X | X | X | X | X |
| Sleep diary evaluation | X | X | X | X | X | X | X | X | |
| Blindness evaluation | X | ||||||||
*
There were 2 to 3 weeks of baseline actigraphy, 8 weeks of treatment, and 2 weeks of placebo washout (P/w).
MMSE refers to Mini-Mental State Examination; ADAS-cog, Alzheimer’s Disease Assessment Scale-cognitive scale; NPI, Neuropsychiatric Inventory; ADCS-ADL, Alzheimer’s Disease Cooperative Study