Table 1.
Method | Outcome | Scales | Visit 1 (Baseline) | Visit 2 (2 Years)˟ | Visit 3 (4 Years)˟ |
---|---|---|---|---|---|
Assessed by trial assessor | Motor functioning in ‘ON’ state | MDS-UPDRS III (including H&Y stage) | X* | X* | X* |
MDS-UPDRS IV | X* | X* | X* | ||
Neuropsychological symptoms | MoCA | X | X | X | |
Phonemic and semantic fluency | X | X | X | ||
15 Words Test | X | X | X | ||
Benton Judgment of Line Orientation | X | X | X | ||
Letter Number Sequencing | X | X | X | ||
Symbol Digit Modalities Test | X | X | X | ||
MDS-UPDRS I | X* | X* | X* | ||
Demographics and lifestyle | Medical history | X | X | X | |
Medication | X | X | X | ||
Biospecimen | EDTA Plasma (DNA) | X | |||
Pax Gene (RNA) | X | ||||
Brain structure and function | Resting-state functional MRI | X | X | X | |
Structural MRI (T1, T2*, neuromelanin, DWI) | X | X | X | ||
Wearable sensors | Motor parameters | IMU including 3-axis accelerometer and 3-axis gyroscope | X | X | X |
Self-reported patient questionnaires | Neuropsychiatric symptoms | BDI | X | X | X |
QUIP-RS | X | X | X | ||
PAS | X | X | X | ||
Quality of life | PDQ-8 | X* | X* | X* | |
Autonomic symptoms | SCOPA-AUT | X | X | X | |
Sleep disorders | RBDQ | X | X | X | |
Various | MDS-UPDRS II | X* | X* | X* |
BDI Beck Depression Inventory, HC healthy controls, H&Y Hoehn and Yahr scale, IMU Inertial Measurement Unit, MDS-UPDRS Movement Disorders Society Unified Parkinson Disease Rating Scale, MoCA Montreal Cognitive Assessment, NPA Neuropsychological assessment, PAS Parkinson Anxiety Scale, PD Parkinson’s disease patients, PDQ-8 Parkinson’s Disease Questionnaire, QUIP-RS Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s disease, RBDSQ REM-sleep behaviour disorder screening questionnaire, SCOPA-AUT Scales for Outcomes in Parkinson’s Disease - Autonomic dysfunction questionnaire
˟ ± 60 days; * Only for PD patients