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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