Visit Name | Screen | Baseline | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Week 18 | Week 26 | Week 34 | Week 42 | Week 52 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Consent | X | |||||||||||
Medical History | ||||||||||||
Medical History | X | |||||||||||
Demographics | X | |||||||||||
Review inclusion and exclusion criteria | X | X | ||||||||||
MRI | X | X | ||||||||||
Randomization | X | |||||||||||
Medication | ||||||||||||
In clinic first dose | X | |||||||||||
Compliance assessment | X | X | X | X | X | X | X | X | X | X | ||
Concomitant Medication Check | X | X | X | X | X | X | X | X | X | X | X | X |
Safety Assessments | ||||||||||||
Adverse Event Review | X | X | X | X | X | X | X | X | X | X | X | |
Interview | X | X | X | X | X | X | X | X | X | X | X | X |
Chemistry Blood Draw | X | X | X | X | X | X | X | X | X | X | X | X |
Hematology Blood Draw | X | X | X | X | X | X | X | X | X | X | X | X |
Coagulation Blood Draw | X | X | X | X | X | X | X | X | X | X | X | X |
Genetics Blood Draw | X | |||||||||||
GCase Blood Draw | X | X | X | X | X | X | X | X | ||||
Ambroxol Blood Draw | X | X | X | X | X | X | X | X | ||||
Urinalysis | X | X | X | X | X | X | X | X | X | X | X | X |
Standing Blood Pressure | X | X | X | X | X | X | X | X | X | X | X | X |
Seating Blood Pressure | X | X | X | X | X | X | X | X | X | X | X | X |
Height | X | |||||||||||
Weight | X | X | X | X | X | X | X | X | X | X | X | X |
ECG | X | X | X | X | X | X | X | X | X | X | X | X |
Physical Exam | X | X | X | X | X | X | X | X | X | X | ||
Neurological Exam | X | X | X | X | X | X | X | X | X | |||
CSF GCase | X | X | X | |||||||||
CSF Ambroxol | X | X | X | |||||||||
CSF Safety | X | X | X | |||||||||
MMSE | X | X | X | X | X | X | X | X | X | X | ||
Gait Kinematics | X | X | X | |||||||||
Timed up and Go | X | X | X | |||||||||
Purdue Pegboard | X | X | X | |||||||||
UPDRS | X | X | X | |||||||||
Cognitive Assessments | ||||||||||||
ADAS-Cog | X | X | X | |||||||||
CGIC | X | X | X | |||||||||
PD-CRS | X | X | X | |||||||||
NPI | X | X | X | |||||||||
CDR | X | X | X | |||||||||
MoCA | X | X | X | |||||||||
Trail Making Test | X | X | X | |||||||||
Stroop test | X | X | X | |||||||||
Geriatric Depression Scale | X | X | X |