Procedure | Screening and inclusion | Baseline imaging | Phone follow-up 1 | Clinical follow-up 1 | Phone follow-up 2 | Clinical follow-up 2 | Follow-up imaging | Clinical follow-up 3 |
---|---|---|---|---|---|---|---|---|
-42 to 1 day(s) before first dose | 1–3 days after first dose | 5–14 days after first dose | 23–56 days after first dose (± 14 days) | 71–105 days after first dose (± 14 days) | -14 to 27 days after last dose | ≤ 28 days after last dose | ||
Check inclusion/exclusion criteria | √ | √ | √ | √ | √ | √ | √ | √ |
Medical history/concomitant medications | √ | √ | √ | √ | √ | √ | ||
Physical and Neurological Examination | √ | √ | √ | √ | ||||
Instructions for taking the study drug | √ | √ | ||||||
Retinal OCTa | √ | √ | ||||||
[18F]FDG PET and qCTa | √ | √ | ||||||
Head/brain MRIa | √ | √ | ||||||
Cardiovascular MRIa | √ | √ | ||||||
Start treatment with study drugc | √ | |||||||
Blood collection d | √ | √b | √ | |||||
Lumbar punctured | √ | √ | ||||||
Cognitive testingd | √ | √ | ||||||
Adverse Events (AE & SAE) | √ | √ | √ | √ | √ | |||
Study end | √ |