Table 1.
Schedule of activities for the UP study
Procedure | Screening | Baseline | Week 12 | Week 24 | Week 36 | Week 48 | Week 56 | |
Medical history | Consent | X | ||||||
Review inclusion/exclusion criteria | X | X | ||||||
Demographics | X | |||||||
Medical history and physical examination | X | |||||||
Height and weight | X | X | ||||||
Genetics Sample | X | |||||||
Medication | Randomisation | X | ||||||
Medication supply | X | X | X | X | ||||
Concomitant medication review | X | X | X | X | X | X | X | |
Compliance review | X | X | X | X | ||||
Clinical assessment/outcome measures | MDS-UPDRS Part 3 ‘OFF’ | X | X | X | ||||
MDS-UPDRS Part 3 ‘ON’ | X | |||||||
MDS-UPDRS Parts 1–4 ‘ON’ | X | X | X | |||||
MoCA, MADRS | X | X | X | |||||
PDQ-39 | X | X | X | |||||
NMS-QUEST | X | X | ||||||
Sensor-based analysis | Dynaport Move Monitor +7 days recording | X | X (7 days prior) | |||||
OptoGait/Opals gait assessment ‘OFF’ | X | X | ||||||
MRI | 31P-MRS | X | X | |||||
Safety monitoring | Safety bloods | X | X | X | X | X | X | X |
ECG | X | X | ||||||
AE review | X | X | X | X | X | X |
AE, adverse event; MADRS, Montgomery-Asberg Depression Rating Scale; MDS-UPDRS, Movement Disorders Society Unified Parkinson’s Disease Rating Scale; MoCA, Montreal Cognitive Assessment; NMS-QUEST, Non-Motor Symptom Questionnaire; PDQ-39, 39-Item Parkinson’s Disease Questionnaire; 31P-MRS, 31Phosphorus MR spectroscopy.