Table 1.
Baseline Characteristics and Baseline Summary Statistics for Each Study
| AL-108–231: Davunetide | 4RTNI: No Drug (PSP) | 4RTNI: No Drug (CBS) | PROSPERA: Rasagaline | TAUROS: Tideglusib | |
|---|---|---|---|---|---|
| N Total (Drug:Placebo) | 153:151 | 0:73 | 0:49 | 22§:22 | 115:31 |
| Age | |||||
| Mean ± SD | 67.6 ± 6.55 | 70.1 ± 7.56 | 66.4 ± 6.76 | 68.3 ± 5.44 | 68.2 ± 7.00 |
| Median (Range) | 68 (45 – 84) | 70 (55 – 86) | 66 (53 – 82) | 69 (50 – 77) | 68 (51 – 85) |
| Gender | |||||
| Female, N (%) | 142 (47) | 40 (55) | 29 (59) | 23 (52) | 62 (43) |
| Race | |||||
| White, N (%) | 266 (88) | 62 (85) | 40 (82) | 44 (100) | 140 (96) |
| PSP Rating Scale Total Score | |||||
| Mean ± SD | 39.7 ± 11.03 | 38.0 ± 16.44 | †27.7 ± 12.20 | *29.1 ± 6.77 | 38.8 ± 12.08 |
| Median (Range) | 39 (9 – 77) | 37 (10 – 86) | 25 (7 – 63) | 28 (17 – 39) | 39 (9 – 67) |
| MMSE Total Score | |||||
| Mean ± SD | 26.3 ± 3.47 | 24.9 ± 4.90 | 24.1 ± 6.37 | ||
| Median (Range) | 27 (15 – 30) | 26 (1 – 30) | 27 (5 – 30) | ||
| SEADL | |||||
| Mean ± SD | 52.2 ± 21.73 | 60.5 ±25.91 | 59.3 ± 21.11 | †78.4 ± 10.10 | 55.4 ± 21.08 |
| Median (Range) | 50 (10 – 100) | 70 (10 – 90) | 60 (10 – 90) | 80 (40 – 90) | 50 (10 – 100) |
| CGIds | |||||
| Mean ± SD | 3.9 ± 0.90 | 4.0 ± 0.92 | 3.8 ±0.73 | 4.2 ± 0.93 | |
| Median (Range) | 4 (2 – 6) | 4 (2 – 6) | 4 (3 – 5) | 4 (2 – 6) | |
| PSP Rating Scale Bulbar | |||||
| Mean ± SD | 2.9 ± 1.47 | 2.9 ± 1.70 | †1.3 ± 1.23 | 2.4 ± 0.97 | 2.8 ± 1.57 |
| Median (Range) | 3.0 (0 – 7) | 3.0 (0 – 6) | 1.0 (0 – 4) | 2.0 (0 – 4) | 3.0 (0 – 8) |
| PSP Rating Scale Gait | |||||
| Mean ± SD | 10.4 ± 3.85 | 10.4 ± 5.35 | †6.7 ± 5.29 | *6.7 ± 1.86 | 10.1 ± 4.22 |
| Median (Range) | 10.0 (0 – 20) | 10.0 (0 – 20) | 6.0 (0 – 19) | 6.5 (4 – 11) | 10.0 (0 – 19) |
| PSP Rating Scale History (Daily Living) | |||||
| Mean ± SD | 8.7 ± 3.38 | 8.4 ± 4.15 | †6.3 ± 3.05 | *6.7 ± 2.32 | 8.1 ± 3.01 |
| Median (Range) | 9.0 (0 – 20) | 8.0 (1 – 20) | 6.0 (1 – 16) | 7.0 (2 – 11) | 8.0 (1 – 16) |
| PSP Rating Scale Limb Motor | |||||
| Mean ± SD | 4.75 ± 2.31 | 5.1 ± 2.73 | †7.9 ± 3.15 | *3.0 ± 1.41 | 5.1 ± 2.36 |
| Median (Range) | 4.0 (0 – 14) | 5.0 (1 – 14) | 7.0 (2 – 15) | 3.0 (0 – 6) | 5.0 (0 – 12) |
| PSP Rating Scale Mentation | |||||
| Mean ± SD | 3.7 ± 2.58 | 3.6 ± 2.45 | 2.9 ± 2.19 | 2.8 ± 1.38 | 3.3 ± 2.62 |
| Median (Range) | 3.0 (0 – 15) | 3.0 (0 – 13) | 2.5 (0 – 11) | 3.0 (0 – 5) | 3.0 (0 – 12) |
| PSP Rating Scale Ocular Motor | |||||
| Mean ± SD | 9.4 ± 2.93 | 7.5 ± 3.97 | †2.6 ± 2.72 | 7.5 ± 2.06 | 9.4 ± 3.28 |
| Median (Range) | 10.0 (2 – 15) | 8.0 (1 – 16) | 2.5 (0 – 11) | 7.0 (4 – 13) | 10.0 (1 – 15) |
Abbreviations: CBS, corticobasal syndrome; CGIds, Clinical Global Impression of Disease Severity; MMSE, Mini Mental State Examination; PSP, progressive supranuclear palsy; SD, standard deviation; SEADL, Schwaab and England Activities of Daily Living.
Significant differences between PROSPERA and all 3 other PSP studies; *p<0.05, †p<0.001.
Significant differences between CBS and pooled mild-moderate PSP studies; *p<0.05, †p<0.001.
Note: At time of writing, for the 4RTNI study, CGIds and SEADL baseline values are available only for 50 PSP patients (out of 73), and 30 CBS patients (out of 49). § Baseline data for patients on Rasagaline not available to author.