Table 1.
Schedule of events for DSBI pilot.
| Visit | Screen/BL | YR1 | YR2 | YR3 (Comp) |
|---|---|---|---|---|
| Month | 0 | 12 | 24 | 36 |
| Study Procedures | ||||
| Screening/administrative | ||||
| Informed consent [/assent] | x | |||
| Inclusion/exclusion criteria | x | |||
| Medical history and demographics | x | |||
| Safety assessments | ||||
| Physical examination | x | x | x | x |
| Vital signs | x | x | x | x |
| Neurocog assessments | ||||
| Scales, questionnaires, etc. | x | x | x | x |
| Clinical laboratory assessments | ||||
| Hematology, Chemistry | x | x | x | x |
| Urinalysis | x | x | x | x |
| Pharmacogenomics (DNA) | ||||
| ApoE | x | |||
| Biomarkers (eg, plasma, serum sample collection) | ||||
| Plasma, serum collection | x | x | x | x |
| Imaging | ||||
| Tau PET | x | x | ||
| Amyvid PET | x | x | ||
| FDG PET | x | x | ||
| vMRI | x | x | x | x |
| Retinal amyloid imaging | x | x | x | x |
| Ongoing subject review | ||||
| Concomitant therapy | x | x | x | x |
| Adverse events | x | x | x | x |