Table 3.
Schedule of assessments (abridged)
| Time point | Screening | Baseline (W1) | Q2 weeks after BL | W4 | Q12 weeks after BL up to W52 | W16 | W26 | W38 | W52 | Q26 weeks after W52 | W104 | W260 | W274 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medical history | X | ||||||||||||
| Physical and neurological examination | X | X | X | X | X | X | X | X | X | X | |||
| Criteria for MCI/AD | X | X | X | X | X | X | |||||||
| GDS | X | X | X | X | X | X | |||||||
| Subjective memory checklist | X | X | X | X | X | X | |||||||
| Screening cognitive battery | X | ||||||||||||
| Composite cognitive battery | X | X | X | X | X | X | X | X | |||||
| Extended cognitive battery | X | X | X | X | X | X | |||||||
| CDR | X | X | X | X | X | X | |||||||
| FAST | X | X | X | X | X | X | |||||||
| NPI | X | X | X | X | X | X | |||||||
| Suicidality assessment | X | X | X | X | X | X | X | X | |||||
| Safety laboratories | X | X | X | X | X | X | X | X | X | X | X | ||
| DNA (APOE, PSEN1); optional DNA for repository | X | ||||||||||||
| ECG | X | X | X | X | X | X | X | X | X | ||||
| PK, PD, and exploratory serum, plasma, RNA samples | X | X | X | X | X | X | X | X | X | X | X | ||
| ATA sample | X | X | X | X | X | X | X | ||||||
| Urine screen for drugs of abuse | X | X | X | X | |||||||||
| Serum pregnancy test | X | ||||||||||||
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Dispense study medication | X | X | X | X | X | X | X | X | X | X | |||
| Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Interval medical history and adverse events | X | X | X | X | X | X | X | X | X | X | X | X | |
| Urine pregnancy test | X | X | X | X | X | X | X | X | X | X | X | X | |
| Brain MRI | X | X | X | X | X | X | X | X | |||||
| Lumbar puncture for CSF samples (optional) | X | X | X | ||||||||||
| Fibrillar amyloid PET imaging | X | X | X | ||||||||||
| FDG PET | X | X | X | X | X |
Abbreviations: AD, Alzheimer's disease; APOE, apolipoprotein; ATA, antitherapeutic antibody; CDR, Clinical Dementia Rating Scale; CSF, cerebrospinal fluid; DNA, deoxyribonucleic acid; ECG, electrocardiogram; FAST, Functional Assessment Staging Test; FDG, fluorodeoxyglucose; GDS, Geriatric Depression Scale; MCI, mild cognitive impairment; MRI, magnetic resonance imaging; NPI, Neuropsychiatric Inventory; PD, pharmacodynamic; PET, positron emission tomography; PK, pharmacokinetic; PSEN1, presenilin 1; RNA, ribonucleic acid.