Table 3.
Secondary Outcome Measures for Cohort 1a
| Outcomes | Placebo
|
Creatine
|
Difference, Mean (95% CI) | ||
|---|---|---|---|---|---|
| No. | Mean (SD) | No. | Mean (SD) | ||
| Total LEDD, (mean at year 5), mgb | 365 | 782 (408) | 366 | 738 (401) | 45 (−14 to 103) |
|
| |||||
| UPDRS (mean change)c | |||||
|
| |||||
| Total | 336 | 10.4 (13.8) | 330 | 11.3 (15.3) | −0.9 (−3.1 to 1.3) |
|
| |||||
| Mental | 339 | 1.1 (1.8) | 333 | 1.2 (1.9) | −0.1 (−0.4 to 0.1) |
|
| |||||
| ADL | 339 | 4.0 (5.1) | 333 | 4.5 (5.7) | −0.5 (−1.3 to 0.3) |
|
| |||||
| Motor | 336 | 5.3 (9.8) | 330 | 5.6 (10.2) | −0.2 (−1.8 to 1.3) |
|
| |||||
| Total functional capacity (mean change)c | 343 | −1.7 (2.4) | 334 | −1.9 (2.7) | 0.2 (−0.2 to 0.6) |
|
| |||||
| Scales for Outcomes in Parkinson disease–Cognition (mean change)c | 315 | −2.0 (4.9) | 309 | −1.9 (5.4) | −0.1 (−0.9 to 0.7) |
|
| |||||
| EQ-5D (mean change)c | 342 | −0.1 (0.2) | 334 | −0.1 (0.2) | 0.005 (−0.03 to 0.04) |
|
| |||||
| BDI score (mean at year 5)c | 335 | 8.5 (6.7) | 329 | 8.6 (6.3) | −0.1 (−1.1 to 0.9) |
|
| |||||
| BDI score >17 (at year 5), No. (%)b | 335 | 29 (8.7%) | 329 | 29 (8.8%) | 0.002 (−0.04 to 0.04) |
|
| |||||
| BMI, mean changec,d | 341 | −0.4 (3.3) | 338 | −0.1 (2.9) | −0.3 (−0.8 to 0.2) |
Abbreviations: ADL, activities of daily living; BDI, Beck Depression Inventory; BMI, body mass index; EQ-5D, EuroQOL instrument; LEDD, levodopa equivalent daily dose; UPDRS, Unified Parkinson Disease Rating scale.
a
Data reported from final interim analysis (July 17, 2013) with the exception of BMI and total LEDD, which are reported from the final locked database (May 5, 2014).
b
Values are means at year 5; BDI score greater than 17 is the difference in proportions at year 5.
c
Values are mean change from baseline to year 5.
d
Calculated as weight in kilograms divided by height in meters squared.