TABLE 3.
Annual Change in Primary, Secondary and Exploratory Outcomes by Treatment Group
| Intensive Treatment Estimate (95% CI) | Standard Treatment Estimate (95% CI) | Mean Difference (95% CI) | P Value | |
|---|---|---|---|---|
| Primary Outcomes | ||||
| Memory Domain | −0·005 (−0·010, 0·001) | −0·001 (−0·006, 0·005) | −0·004 (−0·012, 0·004) | 0·33 |
| Processing Speed Domain | −0.025 (−0.030, −0.019) | −0·015 (−0·021, −0·009) | −0·010 (−0·017, −0·002) | 0·02 |
| Secondary Outcomes | ||||
| Montreal Cognitive Assessment (0 to 30) | −0·04 (−0·07, −0·01) | −0·04 (−0·07, −0·01) | 0·00 (−0·05, 0·04) | 0·95 |
| Logical Memory I (0 to 28) | 0·13 (0·09, 0·17) | 0·12 (0·08, 0·16) | 0·01 (−0·05, 0·06) | 0·79 |
| Logical Memory II (0 to 14) | 0·12 (0·09, 0·15) | 0·11 (0·08, 0·14) | 0·00 (−0·04, 0·05) | 0·84 |
| Digit Symbol Coding (0 to 135) | −0·43 (−0·51, −0·35) | −0·32 (−0·40, −0·24) | −0·11 (−0·22, 0·00) | 0·06 |
| HVLT-R Delayed Recall (0 to 12) | 0·08 (0·04, 0·12) | 0·12 (0·09, 0·16) | −0·05 (−0·10, 0·01) | 0·10 |
| mROCF Immediate Recall (0 to 24) | −0·47 (−0·52, −0·43) | −0·40 (−0·45, −0·36) | −0·07 (−0·13, −0·01) | 0·02 |
| Boston Naming Test-15 (0 to 15) | −0·01 (−0·02, 0·01) | −0·02 (−0·04, 0·00) | 0·01 (−0·01, 0·04) | 0·27 |
| Category Fluency - Animals (0 to No Limit) | −0·12 (−0·17, −0·08) | −0·13 (−0·17, −0·08) | 0·00 (−0·06, 0·07) | 0·95 |
| Trail Making Test - Part A (seconds) | 0·43 (0·30, 0·57) | 0·12 (−0·01, 0·26) | 0·31 (0·12, 0·50) | 0·001 |
| Trail Making Test - Part B (seconds) | 1·28 (0·80, 1·76) | 0·94 (0·46, 1·42) | 0·34 (−0·34, 1·02) | 0·33 |
| Trail Making Test - Part B minus Part A (seconds) | 0·84 (0·35, 1·33) | 0·62 (0·13, 1·10) | 0·23 (−0·46, 0·92) | 0·52 |
| Digit Span (0 to 32) | −0·02 (−0·05, 0·01) | −0·01 (−0·05, 0·02) | 0·00 (−0·05, 0·04) | 0·84 |
| Exploratory Outcomes | ||||
| Language | −0·014 (−0·019, −0·001) | −0·015 (−0·020, −0·009) | 0·001 (−0·007, 0·009) | 0·84 |
| Executive Function | −0·010 (−0·016, −0·003) | −0·006 (−0·012, −0·006) | −0·004 (−0·013, 0·005) | 0·40 |
| Global Cognitive Function | −0·016 (−0·021, −0·012) | −0·011 (−0·015, −0·006) | −0·006 (−0·012, 0·001) | 0·09 |
Estimates for primary and exploratory outcomes represent annual slope assuming linear change over time based on a linear mixed model. Estimates for secondary outcomes similarly assume linear change over time but are based on a robust formulation of a linear mixed model (See Supplemental Methods, page 4). CI denotes confidence interval, HVLT-R Hopkins Verbal Learning Test – Revised, and mROCF modified Rey-Osterreith Complex Figure.