Table 1.
Schedule of assessments.
| Procedure: | Visit Freq.
|
|||
|---|---|---|---|---|
| Baseline, Yr 1 & 2 | Every 6 mo. | Every 3 mo. | Every 1 mo. | |
| Informed consent | X(b-line) | |||
| Vitals & Med/Tx History | X | X | ||
| Clinical Assessment | X | |||
| PE & Neuro Exam | X | |||
| Genetics/APOE | X(b-line) | |||
| Pregnancy testing | X | X | ||
| 12-lead ECG | X | X | X | |
| Hem/Chem/LFTs/UA | X | X | X | |
| Safety MRI | X | X | ||
| C-SSRS | X | X | ||
| Cognitive Testing | X | |||
| vMRI, PET: PIB & FDG | X | |||
| Blood (pK, biomarkers) | X | |||
| LP-CSF | X | |||
| AE/SAE Assessment | X | X | ||
| Randomization | X(b-line) | |||
| Study drug admin | X | X | ||
AE: adverse event; CSF: cerebrospinal fluid; C-SSRS: columbia suicide severity rating scale; LP: lumbar puncture; SAE: serious adverse event; LFT: liver function test; UA: urinalysis; HEM: hematology; CHEM: chemistry; PE: physical exam; vMRI: volumetric magnetic resonance imaging;