Semax in cognitive performance and neuroprotection: effect on the anchor outcome
In the population defined for cognitive performance and neuroprotection, what is the effect of Semax compared with the comparator used in its contributing trials on the anchor outcome for this indication?
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.
§1Abstract
§1.1Review question
In the population defined for cognitive performance and neuroprotection, what is the effect of Semax compared with the comparator used in its contributing trials on the anchor outcome for this indication?
§1.2PICO frame
Table 1. The registered PICO frame. Any change made after protocol registration is recorded in the amendment log at §5 and is identified there as post hoc.
| Element | As registered |
|---|---|
| Population | Domain-specific cognitive function or protection against cognitive decline, assessed by standardised neuropsychological batteries or clinical dementia rating. |
| Intervention | Semax administered as intranasal in the approved russian presentations; also supplied for subcutaneous use. |
| Comparator | The comparator used in each contributing trial, reported per trial rather than pooled across comparator types. |
| Outcomes | Anchor outcome for this indication: Domain-specific cognitive test scores. Additional outcomes: Clinical Dementia Rating sum of boxes; Biomarker change (amyloid, tau, neurofilament light). |
§1.3Method in brief
A review of the effects of an intervention on pre-specified outcomes, with a quantitative synthesis where the contributing studies are sufficiently similar. The protocol was registered with the Institute's secretariat before the search was executed. The search was run on 4 June 2024 across 8 sources and is reproduced in full at §2. Screening, extraction and certainty assessment were performed independently by two members of the secretariat with disagreement resolved by a third.[1,2]
§1.4Conclusion
Very low certainty evidence from 2 contributing trials bears on the effect of Semax on the anchor outcome for cognitive performance and neuroprotection. The estimate the Institute carries in the monograph is: Russian clinical studies report functional improvement after ischaemic stroke and in cognitive disorders. Downgraded to very low for risk of bias and reporting limitations rather than for absence of studies. The Institute distinguishes these two reasons for a low rating and states which applies in every assessment.
The conclusion rests on 2 contributing studies, listed with their extracted data at §3 and summarised outcome by outcome at §4.
§1.5Limitations
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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- 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
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