Summary of findings 3. Souvenaid compared to placebo for mild‐to‐moderate Alzheimer's dementia.
| Souvenaid compared to placebo for mild‐to‐moderate Alzheimer's disease | ||||||
| Patient or population: People with mild‐to‐moderate Alzheimer's dementia Setting: community Intervention: Souvenaid Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with Souvenaid | |||||
| Cognition (global cognitive function) Assessed with: ADAS‐cog Follow‐up: 24 weeks |
Single study reported no significant difference between Souvenaid and placebo based on available‐case analysis (MD 1.02, 95% CI −1.11 to 3.15), or when missing data were considered in a mITT analysis (MMRM: MD 0.37; P = 0.51) | ‐ | 527a (1 RCT) | ⊕⊕⊕⊝ MODERATEb | Souvenaid probably results in little to no difference in cognition | |
| Memory (specific cognitive function) Assessed with: No study measured this outcome Follow‐up: 24 weeks |
‐ | ‐ | (0 studies) | ‐ | ‐ | |
| Executive function (specific cognitive function) Assessed with: Global cognitive function composite z‐score (4 components) Follow‐up: 24 weeks |
Single study reported no significant difference between Souvenaid and placebo based on available case analysis (MD 0.08, 95% CI −0.07 to 0.23), or when missing data were considered in a mITT analysis (MMRM P = 0.32)c | ‐ | 527a (1 RCT) | ⊕⊕⊕⊝ MODERATEb | Souvenaid probably results in little to no difference in executive function | |
| Activities of daily living (functional outcome) Assessed with: ADCS‐ADL Follow‐up: 24 weeks |
Single study reported no significant difference between Souvenaid and placebo based on available case analysis (MD 0.51, 95% CI −2.4 to 3.42), or when missing data were considered in a mITT analysis (MMRM P = 0.77) | ‐ | 527a (1 RCT) | ⊕⊕⊕⊝ MODERATEb | Souvenaid probably results in little to no difference in functional outcome (activities of daily living) | |
| Quality of life, Assessed with: No study measured this outcome |
‐ | ‐ | (0 studies) | ‐ | ‐ | |
| Combined cognitive‐functional outcome Assessed with: CDR‐SoB Follow‐up: 24 weeks |
Single study reported no significant difference between Souvenaid and placebo based on available‐case analysis (MD −0.12, 95% CI −0.74 to 0.50), or when missing data were considered in a mITT analysis (MMRM P = 0.50) | ‐ | 527a (1 RCT) | ⊕⊕⊕⊝ MODERATEb | Souvenaid probably results in little to no difference in the combined cognitive‐functional outcome. | |
| Any adverse events Follow‐up: 24 weeks |
635 per 1000 | 571 per 1000 (495 to 654) |
RR 0.90 (0.78 to 1.03) | 524 (1 RCT) | ⊕⊕⊕⊝ MODERATEb | Souvenaid probably results in little to no difference in any adverse events |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; MD: Mean difference; mITT: Modified intention to treat MMRM: Mixed model for repeated measures; ADAS‐cog: Alzheimer's Disease Assessment Scale‐Cognitive Subscale; ADCS‐ADL: Alzheimer's Disease Cooperative Study Activities of Daily Living; CDR‐SoB: Clinical Dementia Rating Scale Sum of Boxes | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aNumber given is number of participants randomised. Number of participants in each analysis varied with method of handling missing participant data.
bDowngraded for imprecision. Broad 95% CI.
cZ‐score.