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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