1 ADAS‐Cog (change from baseline at 24 weeks) ITT |
1 |
543 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.6 [‐3.72, ‐1.48] |
2 TMT‐A (change from baseline at 24 weeks) ITT |
1 |
496 |
Mean Difference (IV, Fixed, 95% CI) |
‐14.2 [‐24.11, ‐4.29] |
3 clock drawing (change from baseline at 24 weeks) ITT |
1 |
520 |
Mean Difference (IV, Fixed, 95% CI) |
0.2 [‐0.34, 0.74] |
4 MMSE (change from baseline at 24 weeks) ITT |
1 |
543 |
Mean Difference (IV, Fixed, 95% CI) |
0.90 [0.32, 1.48] |
5 ADCS‐ADL (change from baseline at 24 weeks) ITT |
1 |
544 |
Mean Difference (IV, Fixed, 95% CI) |
2.3 [0.52, 4.08] |
6 NPI‐12 (change from baseline at 24 weeks) ITT |
1 |
544 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.60 [‐2.88, 1.68] |
7 withdrawals before end of treatment at 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.90 [1.22, 2.97] |
8 at least one adverse event by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.28 [1.64, 3.16] |
9 withdrawals due to an adverse event before end of treatment at 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.80 [0.93, 3.46] |
10 at least one adverse event of dizziness by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.14 [1.31, 7.50] |
11 at least one adverse event of nausea by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
5.12 [2.85, 9.22] |
12 at least one adverse event of vomiting by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
6.77 [3.38, 13.53] |
13 at least one adverse event of weight decrease by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
6.12 [2.09, 17.92] |
14 at least one adverse event of decreased appetite by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
5.19 [1.49, 18.12] |
15 at least one adverse event of headache by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.66 [0.94, 7.56] |
16 at least one adverse event of asthenia by 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.05 [0.82, 11.38] |
17 deaths before end of treatment at 24 weeks |
1 |
605 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.67 [0.40, 7.06] |
18 NPI‐D carer distress scale (change from baseline at 24 weeks) ITT |
1 |
544 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐1.07, 1.07] |