TABLE 3.
Cognitive secondary endpoints and response to intervention as per protocol analysis
| Improved performance | 0 mo | 3 mo | 12 mo | P_group | P_time | P_group ×time | |
|---|---|---|---|---|---|---|---|
| Power of attention (ms)1,2 | |||||||
| Control (n = 101) | Lower | 1324 (142) | 1322 (133) | 1330 (138) | 0.058 | 0.554 | 0.934 |
| OM3FLAV (n = 94) | 1343 (158) | 1354 (172) | 1361 (204) | ||||
| Continuity of attention (#)1,2 | |||||||
| Control (n = 101) | Higher | 91.6 (3.5) | 92.0 (2.8) | 92.0 (2.7) | 0.502 | 0.833 | 0.921 |
| OM3FLAV (n = 94) | 91.7 (3.0) | 91.8 (2.6) | 91.7 (4.5) | ||||
| Reaction time variability (%)1,2 | |||||||
| Control (n = 101) | Lower | 51.4 (10.5) | 49.6 (9.9) | 49.1 (9.0) | 0.007 | 0.624 | 0.907 |
| OM3FLAV (n = 94) | 50.4 (10.8) | 51.4 (12.0) | 51.0 (9.5) | ||||
| Cognitive reaction time (ms)1,2 | |||||||
| Control (n = 101) | Lower | 207.1 (72.0) | 211.3 (68.7) | 209.0 (71.8) | 0.880 | 0.588 | 0.716 |
| OM3FLAV (n = 94) | 221.5 (73.3) | 219.8 (69.2) | 214.2 (71.2) | ||||
| Quality of working memory (SI)1,2 | |||||||
| Control (n = 101) | Higher | 1.74 (0.31) | 1.81 (0.28) | 1.79 (0.29) | 0.060 | 0.659 | 0.934 |
| OM3FLAV (n = 94) | 1.73 (0.35) | 1.75 (0.35) | 1.75 (0.33) | ||||
| Quality of episodic memory (#)1,2 | |||||||
| Control (n = 101) | Higher | 174.2 (50.0) | 184.2 (51.4) | 178.6 (61.7) | 0.300 | 0.747 | 0.290 |
| OM3FLAV (n = 94) | 176.0 (56.4) | 177.2 (52.0) | 181.6 (53.9) | ||||
| Quality of memory (#)1,2 | |||||||
| Control (n = 101) | Higher | 347.8 (65.6) | 364.5 (69.1) | 357.1 (80.0) | 0.105 | 0.536 | 0.408 |
| OM3FLAV(n = 94) | 347.3 (72.3) | 351.6 (70.7) | 355.3 (73.1) | ||||
| Speed of memory (ms)1 | |||||||
| Control (n = 101) | Lower | 4264 (821) | 4183 (924) | 4197 (891) | 0.094 | 0.796 | 0.680 |
| OM3FLAV (n = 94) | 4332 (1239) | 4362 (1170) | 4272 (1239) | ||||
| Executive function task (#)1,2 | |||||||
| Control (n = 101) | Higher | 118.6 (21.7) | 119. 5 (22.5) | 119.9 (23.8) | <0.001 | 0.660 | 0.758 |
| OM3FLAV (n = 94) | 118. 5 (25.3) | 114.6 (25.8) | 113.3 (25.4) | ||||
| Alertness (ms)1 | |||||||
| Control (n = 101) | Higher | 68.2 (16.0) | 69.9 (14.2) | 69.5 (14.7) | <0.001 | 0.381 | 0.487 |
| OM3FLAV (n = 94) | 68.5 (14.7) | 66.0 (17.9) | 64.0 (17.3) | ||||
| MoCA (#) | |||||||
| Control (n = 101) | Higher | 27.2 (1.9) | 26.9 (2.2) | 27.4 (2.2) | 0.401 | 0.459 | 0.755 |
| OM3FLAV (n = 94) | 27.0 (2.1) | 27.1 (2.2) | 27.5 (2.2) | ||||
| Verbal fluency C1 (#) | |||||||
| Control (n = 101) | Higher | 12.5 (3.4) | 12.6 (3.5) | 0.724 | 0.330 | 0.329 | |
| OM3FLAV (n = 94) | 12.3 (3.5) | 12.6 (3.6) | |||||
| Verbal fluency C3a (#) | |||||||
| Control (n = 101) | Higher | 11.5 (3.6) | 12.0 (3.6) | 0.812 | 0.215 | 0.092 | |
| OM3FLAV (n = 94) | 12.1 (3.3) | 11.9 (4.3) | |||||
| iPosition (pixels) (Original misplacement) | |||||||
| Control (n = 100) | Lower | 241.9 (72.0) | 237.9 (81.4) | 231.1 (77.8) | 0.335 | 0.135 | 0.151 |
| OM3FLAV (n = 90) | 250.8 (69.6) | 235.7 (71.1) | 236.3 (78.1) | ||||
| iPosition (#) Accuracy single item placement | |||||||
| Control (n = 100) | Higher | 2.45 (0.61) | 2.49 (0.65) | 2.51 (0.61) | 0.998 | 0.014 | 0.427 |
| OM3FLAV (n = 90) | 2.37 (0.63) | 2.44 (0.62) | 2.45 (0.66) | ||||
Data are mean (SD); ANCOVA using mixed models for repeated measures. TREATMENT was fitted as a fixed between-group factor (2 levels: intervention or control group). Change from baseline was calculated for all outcome variables (ie, 3 mo-0 mo and 12 mo-0 mo), and VISIT was fitted as a fixed repeated factor (2 levels: 3 and 12 mo). BASELINE (predose scores), study site, BMI, and years of education were added as covariates in the final model.
part of the CDR test battery
a composite measure; Verbal Fluency C1- condition 1, letter fluency, total correct and scaled for age; Verbal Fluency C3a- condition 3, category switching, total correct responses and scaled for age; # Number of items. CDR, Cognitive Drug Research; OM3FLAV, omega-3 polyunsaturated fatty acids (EPA+DHA; OM3) + cocoa flavan-3-ols (FLAV).