Semax in cognitive performance and neuroprotection: effect on the anchor outcome — summary of findings
Outcome-by-outcome summary with effect, certainty and the reason for each downgrade.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§4Summary of findings
§4.1Summary of findings
Table 7. Summary of findings for Semax in cognitive performance and neuroprotection: effect on the anchor outcome.
| Outcome | Participants (studies) | Effect as reported | Certainty | Reason for downgrade |
|---|---|---|---|---|
| Domain-specific cognitive test scoresThe outcome the Institute designates as anchor for this indication. | — (2) | Registered in the Russian Federation on a national evidence base the Institute has not been able to retrieve in full. No trial… | Very low | indirectness, imprecision, publication bias |
| Discontinuation for adverse eventsReported as a summary-of-findings row rather than in a tolerability annex, following a public submission. | — (1) | Reported per contributing trial; see the included-studies table | Very low | inconsistency, indirectness, publication bias |
| Serious adverse eventsEvent counts are low; the estimate is imprecise by construction. | — (1) | Reported per contributing trial; see the included-studies table | Very low | inconsistency, indirectness, imprecision |
| Any adverse eventAscertained by spontaneous report in the contributing trials. | — (2) | Reported per contributing trial; see the included-studies table | Very low | risk of bias, inconsistency, indirectness |
| Clinical Dementia Rating sum of boxesA secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | — (1) | Reported as a secondary outcome in a subset of contributing trials | Very low | risk of bias, inconsistency |
| Biomarker change (amyloid, tau, neurofilament light)A secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | — (1) | Reported as a secondary outcome in a subset of contributing trials | Very low | inconsistency, indirectness |
| Certainty ratings describe confidence in the effect estimate for the stated outcome. They are not recommendations and do not transfer between outcomes. | ||||
§4.2Forest plot
§4.3Certainty assessment for the anchor outcome
Table 8. Reasoning recorded against each certainty domain for the anchor outcome.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | The outcome is a surrogate whose relationship to the clinical outcome is unvalidated for this indication. |
| Imprecision | Serious | The event count falls below the optimal information size. |
| Publication bias | Serious | Too few contributing studies for a formal assessment; the risk cannot be excluded. |
| Overall: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.