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Table 1 Baseline demographics and clinical characteristics

From: Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson’s disease trial

  Screen failed prior to DaT-SPECT collection DaT-SPECT screened DaT-SPECT “abnormal” DaT-SPECT “normal”
N 85 398 383 15
Male 54 (63.5) 280 (70.5) 269 (70.4) 11 (73.3)
Caucasian 75 (88.2) 360 (90.7) 348 (91.1) 12 (80.0)
Age at enrollment, y 63.8 ± 9.73 60.0 ± 8.99 60.1 ± 9.00 58.6 ± 8.96
PD classification
 TD 53 (67.1) 281 (70.8) 273 (71.5) 8 (53.3)
 PIGD 22 (27.8) 84 (21.2) 79 (20.7) 5 (33.3)
 Indeterminate 4 (5.1) 32 (8.1) 30 (7.9) 2 (13.3)
Time since disease onset at enrollment, y 2.5 ± 2.34 1.9 ± 1.76 1.9 ± 1.72 2.7 ± 2.69
Time since PD diagnosis, y 0.6 ± 0.62 0.7 ± 0.64 0.7 ± 0.64 0.5 ± 0.59
Prior PD medication historya 9 (10.6) 70 (17.6) 68 (17.8) 2 (13.3)
MDS-UPDRS score
 Total (I + II + III) 36.0 ± 16.73 32.3 ± 12.91 32.6 ± 12.91 24.9 ± 8.87
 Part I 5.4 ± 4.89 4.4 ± 3.61 4.4 ± 3.64 5.1 ± 2.81
 Part II 6.2 ± 4.93 5.3 ± 3.92 5.4 ± 3.95 3.7 ± 2.55
 Part III 24.4 ± 10.78 22.5 ± 9.12 22.8 ± 9.15 16.2 ± 5.53
Max UPDRS resting tremor 1.1 ± 0.96 1.2 ± 0.99 1.2 ± 0.99 0.9 ± 0.88
Posture stability score (UPDRS 3.12) 0.3 ± 0.72 0.1 ± 0.36 0.1 ± 0.37 0.0 ± 0.00
Hoehn and Yahr scale
 1 18 (24.0) 104 (26.3) 96 (25.2) 8 (53.3)
 1.5 5 (6.7) 23 (5.8) 22 (5.8) 1 (6.7)
 2 38 (50.7) 250 (63.1) 244 (64.0) 6 (40.0)
 2.5 10 (13.3) 17 (4.3) 17 (4.5) 0 (0)
 3 4 (5.3) 2 (0.5) 2 (0.5) 0 (0)
S&E ADL score 92.7 ± 6.81 92.2 ± 7.24 92.2 ± 7.30 92.7 ± 5.94
MoCA score 25.6 ± 3.96 27.4 ± 1.87 27.4 ± 1.88 27.4 ± 1.88
PASE score Not available 168.3 ± 86.74 168.3 ± 86.74 Not available
  1. Data are N (%) or mean ± SD
  2. DaT-SPECT dopamine transporter single-photon emission computed tomography, MDS-UPDRS Movement Disorder Society revision of the Unified Parkinson’s Disease Rating Scale, MoCA Montreal Cognitive Assessment, PASE Physical Activity Scale of the Elderly, PD Parkinson’s disease, PIGD postural instability/gait difficulty, S&E ADL Schwab and England Activities of Daily Living, TD tremor dominant
  3. a Termination of PD medication use must have occurred at least 12 weeks prior to day 1 of the study and for a maximum total duration not exceeding 30 days