Table 4.
Differences in primary outcomes between CEE-Alone and placebo at WHISCA enrollment and over follow-up, adjusted for time since randomization
| Measure | Difference (CEE only minus placebo) at initial WHISCA assessment
|
Overall changes with time
|
Difference (CEE only minus placebo): on-study rates of change (units/yr)
|
Difference (CEE only minus placebo): on-study rates of change (units/yr) for subgroup with four visits
|
|||
|---|---|---|---|---|---|---|---|
| Mean (se) | P value | P value | Mean (se) | P value | Mean (se) | P value | |
| Verbal knowledge | |||||||
| PMA vocabulary | −1.11 (0.67) | 0.098 | <0.0001 | 0.11 (0.11) | 0.326 | 0.10 (0.14) | 0.493 |
| Verbal fluency | |||||||
| Letter fluency | −1.17 (0.83) | 0.162 | <0.0001 | −0.26 (0.19) | 0.175 | −0.36 (0.25) | 0.152 |
| Category fluency | −0.81 (0.42) | 0.057 | <0.0001 | 0.03 (0.11) | 0.760 | −0.04 (0.14) | 0.765 |
| Memory | |||||||
| BVRT errors | 0.38 (0.26) | 0.151 | 0.008 | 0.11 (0.07) | 0.115 | 0.08 (0.08) | 0.318 |
| CVLT total list A trials | −0.62 (0.42) | 0.144 | −0.19 (0.14) | 0.174 | −0.40 (0.17) | 0.022 | |
| CVLT total list B | −0.09 (0.14) | 0.521 | −0.06 (0.05) | 0.296 | −0.02 (0.07) | 0.757 | |
| CVLT short delay free | −0.00 (0.21) | 0.979 | −0.08 (0.07) | 0.234 | −0.16 (0.08) | 0.054 | |
| CVLT long delay free | −0.04 (0.20) | 0.840 | −0.08 (0.07) | 0.242 | −0.19 (0.08) | 0.027 | |
| Attention and working memory | |||||||
| Digits forward | −0.21 (0.13) | 0.118 | 0.337 | 0.03 (0.04) | 0.396 | 0.04 (0.05) | 0.480 |
| Digits backward | −0.04 (0.14) | 0.780 | 0.061 | −0.05 (0.04) | 0.170 | −0.07 (0.05) | 0.171 |
| Spatial ability | |||||||
| Card rotations | −5.28 (1.87) | 0.005 | <0.0001 | 1.26 (0.48) | 0.008 | 1.41 (0.60) | 0.019 |
| Fine motor speed | |||||||
| Finger tapping dom | −1.12 (0.51) | 0.028 | <0.0001 | −0.01 (0.15) | 0.942 | 0.03 (0.18) | 0.879 |
| Finger tapping nondom | −0.59 (0.44) | 0.178 | 0.055 | −0.10 (0.12) | 0.360 | −0.03 (0.14) | 0.830 |
| Affect | |||||||
| PANAS positive | −0.04 (0.05) | 0.335 | 0.353 | 0.01 (0.01) | 0.479 | 0.01 (0.02) | 0.541 |
| PANAS negative | −0.00 (0.04) | 0.907 | 0.381 | −0.01 (0.01) | 0.455 | 0.01 (0.02) | 0.739 |
| GDS | −0.16 (0.16) | 0.306 | 0.034 | −0.08 (0.05) | 0.116 | −0.06 (0.06) | 0.339 |
| 3MS score | −0.42 (0.22) | 0.060 | 0.349 | 0.08 (0.08) | 0.327 | 0.09 (0.10) | 0.332 |
Positive values indicate higher scores (initial assessment) and lower rates of decline for the CEE compared with placebo group; significant overall changes with time indicate significant improvements in performance over time. Higher BVRT scores reflect poorer performance. PMA, Primary mental abilities; dom, dominant hand; nondom, nondominant hand; PANAS, Positive and Negative Affect Schedule; GDS, Geriatric Depression Scale.