Skip to main content

Table 1 List of assessments performed in each visit

From: Ambroxol as a novel disease-modifying treatment for Parkinson’s disease dementia: protocol for a single-centre, randomized, double-blind, placebo-controlled trial

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
  1. Legend: MRI Magnetic Resonance Imaging, GCase Glucocerebrosidase, ECG Electrocardiogram, CSF Cerebrospinal Fluid, MMSE Mini-Mental State Examination, UPDRS Unified Parkinson’s disease rating scale, ADAS-Cog Alzheimer’s disease Assessment Scale-cognitive subscale, CGIC ADCS–Clinician’s Global Impression of Change, PD-CRS Parkinson’s disease Cognitive Rating Scale, NPI Neuropsychiatric Inventory, CDR Clinical Dementia Rating Scale, MoCA Montreal Cognitive Assessment