TABLE 1.
Scores in the rating scales at baseline, 26 weeks, and 52 weeks (1 year) follow-up and their 1-year difference
| Rating scales | Baseline mean (SD) | After 26 weeks mean (SD) | After 52 weeks mean (SD) | One-year difference mean (SD) |
|---|---|---|---|---|
| Both studies | ||||
| SEADL | N = 187, 156 derived from the davunetide study 0.54 (0.21) |
N = 156, 133 derived from the davunetide study 0.47 (0.22) |
N = 141, 120 derived from the davunetide study 0.38 (0.22) |
−0.18 (0.18) |
| PSPRS | N = 187, 156 derived from the davunetide study |
N = 156, 133 derived from the davunetide study |
N = 144, 123 derived from the davunetide study |
|
| Total score | 39.59 (10.97) | 44.55 (12.49) | 49.96 (13.98) | 11.24 (9.95) |
| Bulbar score | 2.82 (1.47) | 3.17 (1.64) | 3.77 (1.80) | 1.00 (1.32) |
| Gait score | 10.39 (3.80) | 11.79 (4.14) | 13.33 (3.96) | 3.33 (3.29) |
| History score | 8.50 (3.42) | 9.71 (3.68) | 10.69 (3.95) | 2.44 (3.30) |
| Limb score | 4.90 (2.18) | 5.48 (2.53) | 6.17 (3.01) | 1.42 (2.25) |
| Mentation score | 3.66 (2.66) | 4.15 (2.83) | 4.83 (3.15) | 1.21 (2.88) |
| Ocular score | 9.32 (3.09) | 10.33 (3.10) | 11.16 (2.91) | 1.83 (2.39) |
| CGIDS | N = 187, 156 derived from the davunetide study 3.99 (0.90) |
N = 25, 2 derived from the davunetide study 4.80 (0.91) |
N = 147, 120 derived from the davunetide study 4.76 (0.94) |
0.84 (0.95) |
| Only davunetide | ||||
| VF | N = 156 10.99 (6.35) |
N = 128 9.97 (6.33) |
N = 1 13 9.12 (6.41) |
−2.23 (4.56) |
| GDS | N = 156 13.14 (6.75) |
N = 131 13.75 (7.36) |
N = 116 14.01 (7.51) |
0.82 (4.89) |
| Only tideglusib | ||||
| FAB | N = 29 10.97 (4.49) |
N = 22 11.68 (3.94) |
N = 18 12.83 (3.94) |
0.56 (2.50) |
| SAS | N = 31 19.58 (8.14) |
N = 21 20.14 (11.05) |
N = 16 20.56 (8.76) |
1.56 (6.64) |
| UPDRSII | N = 31 21.87 (5.68) |
N = 24 23.96 (6.82) |
N = 21 28.67 (7.40) |
7.43 (5.94) |
| LVF | N = 31 9.03 (7.00) |
N = 22 11.73 (9.77) |
N = 19 12.21 (7.17) |
2.26 (5.67) |
| CVF | N = 31 19.23 (10.11) |
N = 22 20.23 (10.62) |
N = 19 17.84 (8.85) |
23.84 (9.05) |
Data are given as mean (standard deviation [SD]). N is the total number of patients from both studies (davunetide and tideglusib). SEADL, Schwab and England Activities of Daily Living Scale; CGIDS, Clinical Global Impression of Disease Severity; PSPRS, Progressive Supranuclear Palsy Rating Scale; VF, verbal fluency (F, A, or S words per minute); FAB, Frontal Assessment Battery; SAS, Starkstein Apathy Scale; UPDRSII, Unified Parkinson’s Disease Rating Scale II; LVF, two letter verbal fluency; CVF, category verbal fluency; GDS: Geriatric Depression Scale.