Table 1:
Data collection and procedures by visit
| All participants | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EN | BL | T1 | T2 | F3 | T4 | F6 | T7 | F9 | T10 | F12 | T18 | T24 | |
| (Weeks from BL) | −3 | 0 | 1 | 2 | 3 | 4.5 | 6 | 7.5 | 9 | 10.5 | 12 | 18 | 24 |
| Procedure | |||||||||||||
| Consent | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Eligibility | X | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ |
| Psychosocial Intervention (PSI) | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Electrocardiogram (ECG), with QTcB interval | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ |
| Medical history | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Telephone interview (brief medical history) | ≅ | ≅ | X | X | ≅ | X | ≅ | X | ≅ | X | ≅ | X | X |
| Basic Metabolic Panel (BMP) | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ||
| Vital signs and weight | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Adverse events | ≅ | X | X | X | X | X | X | X | X | X | X | X | X |
| Assessment | |||||||||||||
| DSM-V Major Depressive Episode (MDE) | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ |
| Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC) | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | X | X |
| Neuropsychiatric Inventory – Clinician Rating (NPI-C), agitation and aggression domains | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| NPI-C (dysphoria domain) | ≅ | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | X | ≅ | ≅ |
| NPI* | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | X | X |
| Activities of Daily Living (ADL) | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | X | X |
| Zarit Burden Interview (ZBI) | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | X | X |
| Caregiver Activity Survey (CAS) | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Get Up and Go Test | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Neurobehavioral Rating Scale (NBRS) | ≅ | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ |
| Mini-Mental State Examination (MMSE) | X | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Number cancellation task (Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-cog) | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Digit span | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Initiation/Perseveration and Conceptualization (Dementia Rating Scale-2, DRS-2) | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Facial Emotion Recognition Test | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Randomized participants, additional schedule of activities† | |||||||||||||
| Procedure | |||||||||||||
| ECG, with QTcB interval | ≅ | X‡ | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| Randomization | ≅ | X | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ |
| Study drug dispensing | ≅ | X | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ | ≅ | ≅ |
| Study drug adherence | ≅ | ≅ | X | X | X | X | X | X | X | X | X | ≅ | ≅ |
| Blood for pharmacokinetics | ≅ | ≅ | ≅ | ≅ | X | ≅ | X | ≅ | X | ≅ | X | ≅ | ≅ |
| BMP | ≅ | ≅ | ≅ | ≅ | X | ≅ | ≅ | ≅ | ≅ | ≅ | X | ≅ | ≅ |
| Routine unmasking | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | ≅ | X | ≅ | ≅ |
Notes: *Only the agitation/aggression domain of the NPI is administered at EN; an abbreviated NPI is administered at BL – F12. †Participants who fail to show improvement on enrollment PSI. If study drug is terminated prior to week 12, the ECG will not occur unless deemed necessary for safety monitoring. ‡Since normal ECG results are a pre-requisite for randomization, only participants likely to be randomized will have the baseline ECG.
EN = Enrollment visit BL = Baseline visit T = Scheduled telephone contact F = Scheduled in-person follow-up visits