Table 2.
Change from Baseline in Participants With at Least 1 Baseline Neuropsychiatric Test Result
| Intention to Treat Population, Mean (SD) |
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|---|---|---|---|---|---|---|---|---|
| Measure | 3 Month | 6 Month | 9 Month | 12 Month | 15 Month | 18 Month | Slope (SD) | P Valuea |
| ADAS-Cog 80, T/P sample sizes: | 769/738 | 775/743 | 776/743 | 776/743 | 777/743 | 786/746 | 786/746 | |
|
| ||||||||
| Tarenflurbil (n = 786) | 0.85 (5.66) | 1.84 (6.08) | 2.02 (7.45) | 4.24 (7.99) | 5.91 (9.19) | 7.27 (10.52) | 5.22 (0.272) | |
|
| ||||||||
| Placebo (n = 746) | 0.81 (4.94) | 1.73 (5.74) | 2.01 (6.57) | 4.28 (7.50) | 5.11 (8.18) | 7.08 (9.24) | 5.06 (0.274) | |
|
| ||||||||
| CFB P Value | .83 | .77 | .93 | .74 | .097 | .86 | .69 | |
|
| ||||||||
| ADCS-ADL, T/P sample sizes: | 727/706 | 740/721 | 742/722 | 742/723 | 742/723 | 751/725 | 751/725 | |
|
| ||||||||
| Tarenflurbil (n = 751) | −1.02 (6.49) | −2.55 (7.84) | −3.92 (8.93) | −5.36 (10.18) | −7.48 (11.65) | −10.20 (13.31) | −7.12 (0.394) | |
|
| ||||||||
| Placebo (n = 725) | −0.65 (6.42) | −2.14 (7.72) | −3.59 (8.78) | −6.05 (10.72) | −7.54 (11.86) | −9.74 (14.01) | −7.08 (0.395) | |
|
| ||||||||
| CFB P Value | .38 | .36 | .58 | .19 | .80 | .48 | .95 | |
|
| ||||||||
| ADAS-Cog 70, T/P sample sizes: | 770/738 | 776/743 | 777/743 | 777/743 | 778/743 | 787/746 | 787/746 | |
|
| ||||||||
| Tarenflurbil (n = 787) | 0.87 (4.86) | 1.73 (5.35) | 1.76 (6.59) | 3.84 (7.29) | 5.45 (8.48) | 6.68 (9.85) | 4.71 (0.259) | |
|
| ||||||||
| Placebo (n = 746) | 0.88 (4.39) | 1.58 (5.09) | 1.72 (5.94) | 3.81 (6.99) | 4.78 (7.57) | 6.44 (8.69) | 4.55 (0.262) | |
|
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| CFB P Value | >.99 | .77 | .89 | .77 | .18 | .87 | .67 | |
|
| ||||||||
| CDR-sb, T/P sample sizes: | 767/738 | 771/743 | 772/743 | 773/743 | 773/744 | 782/746 | 782/746 | |
|
| ||||||||
| Tarenflurbil (n = 782) | 0.41 (1.36) | 0.84 (1.76) | 1.30 (2.09) | 1.67 (2.35) | 2.19 (2.71) | 2.91 (3.21) | 1.95 (0.092) | |
|
| ||||||||
| Placebo (n = 746) | 0.32 (1.43) | 0.64 (1.74) | 1.02 (2.08) | 1.49 (2.47) | 1.99 (2.80) | 2.43 (3.12) | 1.69 (0.093) | |
|
| ||||||||
| CFB P Value | .52 | .091 | 041 | .26 | .24 | .0036 | .046 | |
|
| ||||||||
| MMSE, T/P sample sizes: | 569/588 | 630/615 | ||||||
|
| ||||||||
| Tarenflurbil (n = 630) | NA | NA | NA | −2.36 (4.10) | NA | −3.65 (5.13) | ||
|
| ||||||||
| Placebo (n = 615) | NA | NA | NA | −2.04 (4.11) | NA | −3.27 (5.09) | ||
|
| ||||||||
| CFB P Value | NA | NA | NA | 0.37 | NA | .27 | b | |
|
| ||||||||
| Neuropsychiatric Inventory, T/P sample sizes: | 747/712 | 755/723 | 757/724 | 757/724 | 757/725 | 767/727 | 767/727 | |
|
| ||||||||
| Tarenflurbil (n = 767) | 0.38 (7.53) | 0.39 (8.35) | 1.57 (9.38) | 2.63 (10.36) | 3.47 (11.76) | 3.99 (12.32) | 3.12 (0.364) | |
|
| ||||||||
| Placebo (n = 727) | −0.28 (8.23) | 0.44 (9.55) | 1.34 (10.41) | 1.74 (10.61) | 2.59 (11.58) | 3.37 (11.88) | 2.63 (0.365) | |
|
| ||||||||
| CFB P Value | .33 | .37 | .71 | .26 | .30 | .47 | .34 | |
|
| ||||||||
| QOL participant, T/P sample sizes: | 538/541 | 556/549 | 570/553 | |||||
|
| ||||||||
| Tarenflurbil (n = 570) | NA | −0.37 (4.96) | NA | −0.18 (5.05) | NA | −0.86 (5.49) | ||
|
| ||||||||
| Placebo (n = 553) | NA | −0.22 (4.81) | NA | −0.54 (5.05) | NA | −0.76 (5.41) | ||
|
| ||||||||
| CFB P Value | NA | .91 | NA | .093 | NA | .84 | b | |
|
| ||||||||
| QOL caregiver, T/P sample sizes: | 546/542 | 563/552 | 578/557 | |||||
|
| ||||||||
| Tarenflurbil (n = 578) | NA | −1.06 (5.08) | NA | −1.71 (5.33) | NA | −2.82 (5.52) | ||
|
| ||||||||
| Placebo (n = 557) | NA | −0.95 (5.18) | NA | −2.07 (4.97) | NA | −2.54 (5.61) | ||
|
| ||||||||
| CFB P Value | NA | .73 | NA | .11 | NA | .51 | b | |
|
| ||||||||
| Caregiver Burden Inventory, T/P sample sizes: | 543/536 | 572/566 | 591/574 | |||||
|
| ||||||||
| Tarenflurbil (n = 591) | NA | 1.88 (11.01) | NA | 4.67 (12.71) | NA | 6.57 (13.40) | ||
|
| ||||||||
| Placebo (n = 574) | NA | 1.54 (10.88) | NA | 4.28 (12.36) | NA | 5.93 (13.04) | ||
|
| ||||||||
| CFB P Value | NA | .92 | NA | .57 | NA | .31 | b | |
Abbreviations: ADAS-Cog, Alzheimer Disease Assessment Scale-Cognitive Subscale; Alzheimer Disease Cooperative Studies-activities of daily living scale; CDR, Clinical Dementia Rating; CFB, change from baseline; MMSE, Mini-Mental State Examination; N/A, not available; T/P, time period.
a
P Values were based on the significance of the time by treatment interaction term in a repeated measures linear mixed model including random intercepts and slopes, baseline score and time as covariates, and factors for treatment group, clinical site, and current acetylcholinesterase inhibitor/memantine use.
b
Ad hoc slope analysis not done due to small number of time points.