Table 1.
Data collection schedule
| Assessment visits and contacts (weeks from baseline)* | |||||||
|---|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
| Procedures | |||||||
| Review of consent | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Review inclusion/exclusion | ✓ | . | ✓ | . | ✓ | . | ✓ |
| Collect demographic information | ✓ | ||||||
| Review history | ✓ | . | ✓ | . | ✓ | . | ✓ |
| Perform ongoing medical monitoring | ✓ | . | ✓ | . | ✓ | . | ✓ |
| Review of medication use | . | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Dispense of study drug | ✓ | . | ✓ | ✓. | ✓ | . | . |
| Patient assessments | |||||||
| AES | ✓ | . | ✓ | . | ✓ | . | ✓ |
| ADCS-CGI | ✓ | . | ✓ | . | ✓ | . | ✓ |
| Digit span | ✓ | . | ✓ | . | ✓ | . | ✓ |
| MMSE | ✓ | . | ✓ | . | ✓ | . | ✓ |
| NPI | ✓ | ✓ | |||||
| Safety measures | |||||||
| Review of adverse events | . | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Blood collection for electrolyte panel | ✓ | . | ✓ | . | ✓ | . | ✓ |
| Review ECG | ✓ | . | ✓ | . | . | . | ✓ |
| Study partner intervention | |||||||
| Psychosocial intervention | ✓ | . | ✓ | . | ✓ | . | ✓ |
AES, Apathy Evaluation Scale, ADCS-CGI, Alzheimer’s Disease Cooperative Study - Clinical Global Impression; NPI, Neuropsychiatric Inventory; MMSE, Mini-mental State Examination
*
In-person clinic visits occur at baseline and weeks 2, 4 and 6 following baseline. Telephone contacts occur at weeks 1, 3, and 5following baseline.