Table 2.
Clinical outcome measures.
| Mean at baseline (SD) | Mean at 3 months (SD) | Mean at 12-months (SD) | Change (Baseline vs. 12 months) | Effect size* | Univariate test* | Multivariate test* | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| p | 100 mg | 250 mg | p | 100 mg | 250 mg | p-value | |||||
| Primary outcome: UPDRS III (motor), points | 20.9 (10.9) | 22.1 (14.3) | 21.6 (14.3) | 19.0 (12.0) | 17.6 (13.2) | 22.6 (18.7) | 17.7 (11.7) | −17.3% | 0.32 | <0.0006 | NA |
| Physical Functioning | |||||||||||
| Sentence height (cm) | 0.9 (0.2) | 0.8 (0.3) | 0.9 (0.3) | 1.0 (0.03) | 1.0 (0.4) | 1.0 (0.4) | 1.2 (0.4) | 33% | 0.91 | <0.0001 | 1.2 |
| Sentence area (cm2) | 7.6 (2.6) | 6.0 (2.3) | 7.1 (3.2) | 8.5 (3.1) | 8.2 (5.2) | 8.0 (4.4) | 9.9 (4.2) | 38% | 0.76 | <0.0001 | −0.83 |
| Cognitive Functioning | |||||||||||
| Fatigue severity scale (points) | 41.2 (10.9) | 43.2 (10.4) | 44.7 (12.5) | 31.4 (8.6) | −26% | 1.17 | <0.0001 | 0.93 | |||
| Geriatric depression scale (points) | 7.6 (6.6) | 14.1 (9.2) | 13.1 (9.7) | Not assessed | 4.8 (5.5) | −58% | 0.92 | 0.0005 | 0.70 | ||
| Fatigue visual analog scale (number) | 6.5 (2.2) | 4.3 (6.8) | 4.6 (6.6) | 7.1 (1.9) | 35% | 0.88 | 0.0002 | 0.27 | |||
| Trail making B first trial (s) | 73.6 (30.5) | 109.3 (138.6) | 95.3 (70.8) | 69.7 (44.9) | 104.7 (123.5) | 92.5 (72.8) | 95.6 (63.3) | 45% | 0.66 | 0.043 | 0.93 |
| Sleep questionnaire (points) | 107.4 (24.0) | 111.1 (18.6) | 105.4 (21.2) | 109.1 (24.5) | 115.4 (18.9) | 107.1 (21.4) | 117 (22) | 7.5% | 0.36 | 0.028 | 1.03 |
| Frontal Beta Rhythm | |||||||||||
| 30-s quiet stance** (%) | 55.2 (16.6) | 54.6 (17.0) | 58.1 (16.5) | 52.4 (19.0) | 59.2 (19.1) | 47.4 (18.4) | 60.9 (13.6) | 13% | 0.43 | 0.066 | 0.41 |
| Stance Postural Stability | |||||||||||
| Centroid frequency ML (Hz) | 1.3 (0.5) | 1.3 (0.2) | 1.3 (0.5) | 1.3 (0.4) | 1.1 (0.4) | 1.3 (0.4) | 1.09 (0.3) | −15% | 0.54 | 0.009 | 0.78 |
| Median frequency ML (Hz) | 0.9 (0.6) | 1.0 (0.4) | 0.8 (0.5) | 1.0 (0.6) | 0.8 (0.4) | 1.0 (0.6) | 0.7 (0.5) | −25% | 0.49 | 0.023 | 0.06 |
| 95% circle sway area (m2/s4) | 0.1 (0.03) | 0.2 (0.5) | 0.1 (0.1) | 0.1 (0.1) | 0.1 (0.1) | 0.1 (0.1) | 0.05 (0.03) | −36% | 0.46 | 0.034 | −1.40 |
| Frequency dispersion ML AD | 0.7 (0.1) | 0.6 (0.1) | 0.7 (0.1) | 0.6 (0.1) | 0.7 (0.1) | 0.6 (0.1) | 0.7 (0.1) | 7% | 0.45 | 0.014 | −0.20 |
| 95% frequency ML (Hz) | 2.8 (0.5) | 2.8 (0.3) | 2.7 (0.6) | 2.7 (0.5) | 2.5 (0.6) | 2.6 (0.6) | 2.5 (0.6) | −8% | 0.41 | 0.031 | 0.29 |
The primary outcome variable (UPDRS III) and other secondary measures in the table indicate an improvement in scores following 12 months of daily 250-mg niacin enhancement. The exception is the first trial of the Trail Making Test, which worsens with disease progression in spite of the niacin supplementation. Other variables were unchanged and are not shown in the table. P, placebo group, 100 mg, 100-mg group, 250 mg, 250-mg group. *The univariate test is based on the one-tailed paired t-test (baseline vs. 12 months). The multivariate test is based on Hotelling’s T-square canonical discrimination pooled within-class standardized canonical coefficients (baseline vs. 12 months). Effect size is based on Cohen’s d (baseline vs. 12 months). **Raw signals were amplified, while ambient noise was removed. The device’s proprietary algorithm was then applied to determine the subjects’ mental states. Higher values indicate an improvement in score. It may mean less distraction, less wandering thoughts, better focus, or decreased anxiety. ML, mediolateral plane.