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Fink HA, Hemmy LS, Linskens EJ, et al. Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Apr. (Comparative Effectiveness Review, No. 223.)
Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia: A Systematic Review [Internet].
Show detailsAppendix Table F.4Primary outcomes summary low and medium risk of bias studies: souvenaid versus placebo
| Drug Comparison | AD Severity | Study Followup N RoB | Cognitive | Function | QoL | Global Staging | Clinical Impression of Change | Harms |
|---|---|---|---|---|---|---|---|---|
| Souvenaid vs. Placebo | Mild AD | Schelten 2012 24 weeks N=259 Low Olde Rikert 2015198 | NTB Total Composite, z-score Mean Change from Baseline (SD) I: 0.12 (0.28) C: 0.04 (0.29) p=0.04 Standardized Mean Difference (95% CI) 0.30 (0.06, 0.54) 24 week trajectory p=0.053 | DAD No difference between groups (p=0.36) | NR | NR | NR | SAEs I: 11 SAEs (10 patients. 7.7%) C: 7 SAEs (6 patients, 4.65%) Withdrawal due to AEs I: 3/130 (2.31%) C: 2/129 (1.55%) |
| Souvenaid vs. Placebo | Mild to Moderate AD | Shah 2013199 24 weeks N=527 Medium | 11-item ADAS-cog Mean Change from Baseline (SD) I: 1.88 (6.44) C: 1.52 (5.63) p=0.55 Mean Difference Between Groups (SE) 0.37 (0.57) p=0.51 | ADCS-ADL, Total Score Mean Change from Baseline (SD) I: -3.74 (9.76) C: -3.66 (8.03) p=0.926 | NR | CDR, Sum of Boxes Mean Change from Baseline (SD) I: 0.77(1.96) C: 0.69 (1.90) p=0.68 | NR | SAEs I: 34 SAEs (27 subjects, 10.2%) C: 36 SAEs (34 subjects, 13.1%) Withdrawal due to AEs I: 2 withdrawals due to SAEs (0.76%) C: 4 withdrawals due to SAEs (1.54%) Confusion I: 0/264 C: 1/260 (0.38%) Falls I: 1/264 (0.38%) 2: 1/260 (0.38%) |
Abbreviations: AD=Alzheimer’s Disease; ADAS-Cog= Alzheimer’s Disease Assessment Scale-Cognitive Subscale; ADCS-ADL= Alzheimer’s Disease Cooperative Study-Activities of Daily Living; AE=Adverse Event; CDR=Clinical Dementia Rating; DAD= Disability Assessment for Dementia; NTB= Neuropsychological Test Battery; NR=Not Reported; RoB=Risk of Bias; SAEs=Serious Adverse Events
- Appendix Table F.4, Primary outcomes summary low and medium risk of bias studies...Appendix Table F.4, Primary outcomes summary low and medium risk of bias studies: souvenaid versus placebo - Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia: A Systematic Review
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