Semax in cognitive performance and neuroprotection — evidence extract
The Institute's graded assessment of Semax for cognitive performance and neuroprotection, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Cognitive performance and neuroprotection
§1.1Question and anchor outcome
- Population
- Domain-specific cognitive function or protection against cognitive decline, assessed by standardised neuropsychological batteries or clinical dementia rating.
- Intervention
- Semax, intranasal in the approved russian presentations; also supplied for subcutaneous use
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Domain-specific cognitive test scores
Additional outcomes the Institute extracts for this indication: Clinical Dementia Rating sum of boxes; Biomarker change (amyloid, tau, neurofilament light).
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Semax in cognitive performance and neuroprotection.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| SEMAX-RU-STROKE | — | Observational | — | Not recorded | — |
| SEMAX-RU-COGNITIVE | — | Observational | — | Not recorded | — |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Very serious | Contributing trials are sponsor-conducted and one is open-label. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: 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. | ||
§1.4What this extract does not establish
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.
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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.