| 1 Clinical Global impression (continuous measure) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.1 CGI‐Severity of disease (change from baseline at 52 weeks) |
1 |
417 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐0.23, 0.03] |
| 1.2 CGI‐C (change from baseline at 52 weeks) |
1 |
417 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [‐0.07, 0.27] |
| 1.3 Clinical Global Impression of Improvement (change from baseline at 24 weeks) |
1 |
23 |
Mean Difference (IV, Fixed, 95% CI) |
0.48 [0.33, 0.63] |
| 2 Severity of dementia |
8 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 2.1 Blessed Dementia Rating Scale (change from baseline at 13 weeks) completers |
1 |
43 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.30 [‐1.30, 0.70] |
| 2.2 Blessed Dementia Rating Scale (change from baseline at 24 weeks) completers |
3 |
241 |
Mean Difference (IV, Fixed, 95% CI) |
0.06 [‐0.55, 0.68] |
| 2.3 Blessed Dementia Rating Scale (change from baseline at 52 weeks) completers |
2 |
368 |
Mean Difference (IV, Fixed, 95% CI) |
0.02 [‐0.57, 0.60] |
| 2.4 Clinical Dementia Rating (CDR)‐Sum of Boxes (change from baseline at 52 weeks) |
2 |
595 |
Mean Difference (IV, Fixed, 95% CI) |
0.16 [‐0.26, 0.59] |
| 2.5 Sickness Impact Profile (change from baseline at 24 weeks) completers |
1 |
27 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.2 [‐8.96, 4.56] |
| 3 Cognition |
13 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 MMSE (change from baseline at 52 weeks) completers |
3 |
771 |
Mean Difference (IV, Fixed, 95% CI) |
0.46 [‐0.15, 1.07] |
| 3.2 MMSE (change from baseline at 24 weeks) completers |
7 |
404 |
Mean Difference (IV, Fixed, 95% CI) |
0.69 [0.09, 1.29] |
| 3.3 MMSE (change from baseline at 12 weeks) completers |
7 |
405 |
Mean Difference (IV, Fixed, 95% CI) |
0.06 [‐0.53, 0.65] |
| 3.4 ADAS‐cog (change from baseline at 52 weeks) completers |
2 |
614 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.04 [‐1.38, 1.30] |
| 3.5 Blessed Information Memory and Concentration Test (change from baseline at 13 weeks) completers |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
1.33 [‐0.33, 2.99] |
| 3.6 Blessed Information and Concentration Test (change from baseline at 52 weeks) completers |
2 |
277 |
Mean Difference (IV, Fixed, 95% CI) |
0.70 [‐0.57, 1.97] |
| 3.7 Modified Mini Mental State Examination (mMMSE) (change from baseline at 24 weeks) completers |
1 |
27 |
Mean Difference (IV, Fixed, 95% CI) |
1.50 [‐1.25, 4.25] |
| 3.8 Kendrick Object Learning Test (change from baseline at 24 weeks) |
4 |
157 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.35 [‐3.34, 0.64] |
| 3.9 Kendrick Digit Copying Test (change from baseline at 24 weeks) |
3 |
102 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.15 [‐5.31, 3.01] |
| 3.10 Kendrick Object Learning Test (change from baseline at 12 weeks) |
3 |
122 |
Mean Difference (IV, Fixed, 95% CI) |
0.84 [0.09, 1.59] |
| 3.11 Word Fluency (Fruit) (change from baseline to 12 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.12 [‐0.30, 0.07] |
| 3.12 Word Fluency (Fruit) (change from baseline to 24 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.37 [‐0.54, ‐0.20] |
| 3.13 Word Fluency (Colours) (change from baseline at 12 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.46 [‐0.62, ‐0.30] |
| 3.14 Word Fluency (Colours) (change from baseline at 24 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.69 [‐0.86, ‐0.52] |
| 3.15 Word Fluency (M‐words) (change from baseline at 12 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.28 [‐1.62, ‐0.93] |
| 3.16 Word Fluency (M‐words) (change from baseline at 24 weeks) |
2 |
113 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.08 [‐1.57, ‐0.60] |
| 3.17 Toulouse‐Pieron (Production) (change from baseline at 12 weeks) |
2 |
65 |
Mean Difference (IV, Fixed, 95% CI) |
0.00 [‐14.01, 10.02] |
| 3.18 Toulouse‐ Pieron (time) (change from baseline at 12 weeks) |
2 |
65 |
Mean Difference (IV, Fixed, 95% CI) |
‐16.39 [‐54.84, 22.06] |
| 3.19 Toulouse‐Pieron (mistakes) (change from baseline at 12 weeks) |
2 |
65 |
Mean Difference (IV, Fixed, 95% CI) |
1.72 [‐3.00, 6.44] |
| 3.20 MMSE (change from baseline at 52 weeks) intention to treat |
1 |
207 |
Mean Difference (IV, Fixed, 95% CI) |
0.5 [‐0.44, 1.44] |
| 3.21 MMSE (change from baseline at 24 weeks) intention to treat |
1 |
207 |
Mean Difference (IV, Fixed, 95% CI) |
0.40 [‐0.42, 1.22] |
| 4 Activities of Daily Living |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 4.1 Activities of Daily Living Scale (change from baseline at 52 weeks) completers |
2 |
614 |
Mean Difference (IV, Fixed, 95% CI) |
0.17 [‐0.33, 0.68] |
| 4.2 Nuremberg Geriatric Daily Activities Scale (change from baseline at 12 weeks) completers |
1 |
187 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.2 [‐5.44, 1.04] |
| 5 Dropouts before end of treatment |
12 |
|
Odds Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 5.1 Between baseline and 12 weeks |
3 |
310 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.17 [0.66, 2.07] |
| 5.2 Between baseline and 24 weeks |
6 |
292 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.17 [0.63, 2.17] |
| 5.3 Between baseline and 52 weeks |
4 |
998 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.75, 1.38] |
| 6 Clinical Global Impression (improved vs no change/ worse) |
10 |
|
Odds Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 6.1 Clinical Global Impression of Improvement (change from baseline at 12 weeks) |
6 |
499 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.90 [1.31, 2.76] |
| 6.2 Clinical Global Impression of improvement ( change from baseline at 24 weeks) |
6 |
233 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.33 [1.31, 4.14] |
| 6.3 CIGIC (change from baseline at 52 weeks) |
2 |
338 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.58, 1.43] |
| 6.4 Clinical Global Impression of Severity at 24 weeks (normal‐mild versus mod‐severe illness) |
3 |
246 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.25 [0.71, 2.20] |
| 6.5 Clinical Global Impression of Efficacy at 24 weeks) |
4 |
260 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.59 [0.34, 1.02] |
| 6.6 Clinical Global Impression of Severity (normal/mild versus mod/severe) at 52 weeks |
1 |
171 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.30 [0.70, 2.41] |
| 6.7 Clinical Global Impression of Efficacy (at 52 weeks) |
1 |
171 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.83 [0.42, 1.64] |
| 7 Dropouts due to adverse events |
11 |
1514 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.60, 1.33] |
| 7.1 Between baseline and 12 weeks |
2 |
274 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.29, 1.53] |
| 7.2 Between baseline and 24 weeks |
5 |
242 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.47, 1.84] |
| 7.3 Between baseline and 52 weeks |
4 |
998 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.56, 1.84] |
| 8 Number suffering at least one adverse event |
10 |
1060 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.70, 1.30] |
| 8.1 Between baseline and 12 weeks |
3 |
431 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.54, 1.70] |
| 8.2 Between baseline and 24 weeks |
8 |
629 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.65, 1.38] |
| 9 Number suffering at least one adverse event of agitation |
3 |
249 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.42 [0.53, 3.85] |
| 9.1 Between baseline and 12 weeks |
2 |
174 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.53 [0.49, 4.79] |
| 9.2 Between baseline and 24 weeks |
1 |
75 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.15, 8.63] |
| 10 Number suffering at least one adverse event of nausea |
6 |
662 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.44, 2.95] |
| 10.1 Between baseline and 52 weeks |
1 |
220 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.06, 15.90] |
| 10.2 Between baseline and 24 weeks |
4 |
212 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.39 [0.47, 4.14] |
| 10.3 Between baseline and 12 weeks |
1 |
230 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.20] |
| 11 Number suffering at least one adverse event of aggression |
2 |
111 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.63 [0.26, 10.31] |
| 11.1 Between baseline and 24 weeks |
2 |
111 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.63 [0.26, 10.31] |
| 12 Number suffering at least one adverse event of confusion and or depression |
4 |
412 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.87 [0.26, 2.95] |
| 12.1 Between baseline and 12 weeks |
1 |
230 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.03 [0.12, 75.06] |
| 12.2 Between baseline and 24 weeks |
3 |
182 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.17, 2.64] |
| 13 Number suffering at least one adverse event of abdominal discomfort or diarrhoea |
4 |
351 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.25, 2.76] |
| 13.1 Between baseline and 52 weeks |
1 |
220 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.49 [0.24, 9.07] |
| 13.2 Between baseline and 24 weeks |
3 |
131 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.49 [0.09, 2.77] |
| 14 Number of deaths |
8 |
1310 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.29, 1.52] |
| 14.1 Between baseline and 12 weeks |
1 |
230 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.20] |
| 14.2 Between baseline and 24 weeks |
4 |
212 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.24, 4.80] |
| 14.3 Between baseline and 52 weeks |
3 |
868 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.58 [0.20, 1.67] |
