Table 2.
Baseline clinical characteristics and change over 6 months
| Historical Controls | Salsalate | YP | P Value | |
|---|---|---|---|---|
| Demographics, baseline | (n = 355) | (n = 9) | (n = 5) | |
| Age, mean (SD) | 68.1 (6.9) | 67.6 (3.1) | 71.8 (3.6) | 0.46a |
| Male, n (%) | 186 (52.4) | 4 (44.4) | 2 (40.0) | 0.76b |
| White, n (%) | 301 (86.4) | 7 (77.8) | 5 (100) | 0.05b |
| Education, mean (SD) | 15.7 (4.1) | — | 16.3 (3.5) | 0.80a |
| Clinical severity, baseline | (n = 313) | (n = 9) | (n = 5) | |
| PSPRS, mean (SD) | 39.2 (11.5) | 37.8 (13.7) | 35.8 (19.1) | 0.77a |
| SEADL, mean % (SD) | 53.2 (22.5) | 58.9 (21.8) | 50 (28.3) | 0.72a |
| CGI‐S, mean (SD) | 3.9 (0.9) | 3.8 (0.8) | 3.8 (1.1) | 0.83a |
| CDR‐SB, mean (SD) | 4.0 (2.9) | 3.8 (2.1) | 4.8 (4.7) | 0.98c |
| Neuropsychological testing, baseline | (n = 318) | (n = 9) | (n = 5) | |
| RBANS, mean (SD) | 73.1 (13.1) | 79.2 (9.7) | 78.2 (19.8) | 0.27a |
| GDS, mean (SD) | 12.7 (6.8) | 9.3 (6.9) | 8.2 (6.2) | 0.09c |
| MMSE, mean (SD) | 26.3 (3.5) | 26.8 (2.8) | 26.8 (4.0) | 0.91c |
| MRI volume, baseline | (n = 226) | (n = 8) | (n = 5) | |
| Midbrain, mean cm3 (SD) | 4.77 (0.62) | 4.91 (0.80) | 4.47 (0.71) | 0.46a |
| Pons, mean cm3 (SD) | 10.88 (1.56) | 11.45 (1.30) | 10.42 (1.78) | 0.47a |
| SCP, mean cm3 (SD) | 0.26 (0.03) | 0.25 (0.03) | 0.25 (0.05) | 0.81a |
| Clinical severity, change | (n = 306) | (n = 9) | (n = 5) | |
| PSPRS, mean change (SD) | +5.6 (7.1) | +5.6 (9.6) | +5.0 (7.1) | 0.98a |
| SEADL, mean change (SD) | –9.2 (14.0) | –15.6 (20.1) | –6.0 (19.5) | 0.37a |
| CGI‐C, mean score (SD) | 4.8 (0.9) | 5.3 (1.0) | 4.8 (0.4) | 0.16a |
| Neuropsychological testing, change | (n = 246) | (n = 8) | (n = 5) | |
| RBANS, mean change (SD) | –6.2 (6.9) | –6.9 (7.6) | –2.4 (10.0) | 0.46a |
| GDS, mean change (SD) | +0.6 (4.9) | +0.8 (5.2) | +2.2 (4.8) | 0.76a |
| MRI volume, change | (n = 226) | (n = 8) | (n = 5) | |
| Midbrain, mean change cm3 (SD) | –0.06 (0.04) | –0.07 (0.03) | –0.06 (0.03) | 0.69a |
| Pons, mean change cm3 (SD) | –0.13 (0.10) | –0.19 (0.13) | –0.12 (0.10) | 0.29a |
| SCP, mean change cm3 (SD) | 0.00 (0.01) | 0.00 (0.01) | 0.00 (0.01) | N/A |
| CSF biomarkers, change | (n = 24) | (n = 8) | (n = 5) | |
| NfL, % change baseline (SD) | +28.6% (86.9) | +44.0% (72.2) | +22.9% (62.6) | 0.96c |
| Aβ, % change baseline (SD) | +4.1% (17.9) | –17.1% (17.5) | –13.8% (27.8) | 0.06c |
| Total tau, % change baseline (SD) | +6.5% (23.3) | –6.2% (5.4) | –0.4% (4.4) | 0.13c |
| pTau181, % change baseline (SD) | –2.8% (12.2) | –3.7% (9.6) | +0.4% (5.7) | 0.58c |
a
One‐way ANOVA.
b
Fisher's exact test.
c
Kruskal‐Wallis' test by ranks.
N/A, not applicable.