Table 2 SPARX3 trial outcomes
Domain | Specific measurement variable | Metric | Method of aggregation | Timepoint(s) | |
|---|---|---|---|---|---|
Primary outcome | |||||
(1) MDS-UPDRS part 3 | Motor sign assessment of Parkinson’s disease | MDS-UPDRS part III | Score at time point assessed | Mean | 12 months |
Secondary outcomes | |||||
(1) DatScan (Dopaminergic activity) | Dopamine neuron function (Brain Imaging) | Striatal specific binding ratio | Value at time point assessed | Mean | 12 months |
(2) Six min walk | Functional capacity | Distance walked in 6 min in meters | Value at time point assessed | Mean | 12 and 18 months |
(3) MDS-UPDRS part 3 | Motor sign assessment of Parkinson’s disease | MDS-UPDRS part III | Score at time point assessed | Mean | 18 months |
(4) Activity Level | Physical activity | Number of daily steps | Value at time point assessed | Mean | 12 and 18 months |
(5) Cognitive Function | Cognitive function | Montreal Cognitive Assessment Scale | Score at time point assessed | Mean | 12 and 18 months |
(6) Peak VO2 | Cardiorespiratory fitness | Peak volume of oxygen consumed | Value at time point assessed | Mean | 12 and 18 months |
(7) The Parkinson Disease Questionnaire (PDQ-39) | Quality of life | PDQ-39 | Score at time point assessed | Mean | 12 and 18 months |
(8) Initiation of dopaminergic therapy | Symptom progression | Time (months) | Month of drug initiation | Time to event | --- |
(9) C-Reactive Protein | Inflammation | CRP protein (mg/L) | Value at time point assessed | Mean | 12 and 18 months |
(10) Brain-derived neurotrophic factor | Neuronal function and survival | BDNF protein (ng/ml) | Value at time point assessed | Mean | 12 and 18 months |
Tertiary outcomes | |||||
(1) Stride Length | Gait | Length of stride (meters) | Value at time point assessed | Mean | 12 and 18 months |
(2) Turning Velocity | Gait | Turning velocity (degrees/second) | Value at time point assessed | Mean | 12 and 18 months |