Treatment of cognitive impairment in patients with cerebral infarction in the internal carotid arteries circulation system: results of a multicentre, randomized, double-blind, placebo-controlled clinical trial
Bibliographic record
Abstract
Objective : to evaluate the efficacy and safety of the Prospecta drug in the treatment of cognitive impairment (CI) in patients with ischemic stroke (IS) in the carotid vascular territory. Material and methods . The double-blind, placebo-controlled, randomized clinical trial enrolled 246 patients aged 40 to 75 years with IS in the carotid vascular territory within 72 hours of stroke onset, moderate CI (<26 points on the Montreal Cognitive Assessment, MoCA), full consciousness (15 points on the Glasgow Coma Scale), moderate severity of stroke (8–12 points on the National Institute of Health Stroke Scale, NIHSS), moderate impairment of activity (2–3 points on the – Modified Rankin Scale, mRs). At visit 1, complaints and medical history were collected, vital signs (VS) and laboratory parameters were recorded, CI was assessed according to MoCA and the Glasgow Coma Scale, NIHSS and mRs were filled out. Patients were randomized into two groups: in the first group they received Prospecta for 90 days, in the second group placebo (PL) following a similar regimen. The groups were comparable in terms of demographic and baseline clinical characteristics. After 90 days, complaints, medical history, VS, laboratory parameters and assessment of CI according to MoCA were recorded, and NIHSS and mRs questionnaires were filled out again. The intention-to-treat (ITT) efficacy analysis was performed based on the results of the treatment and follow-up of the Full analysis set (FAS), which comprised 241 patients (122 patients in the Prospecta group and 119 patients in the PL group; 4 patients were excluded from the ITT analysis because they were erroneously included in the study). The results of the per-protocol (PP) analysis are shown in square brackets. Results . The 90-day use of Prospecta reduced the severity of CI in patients with carotid IS compared with placebo therapy. MoCA scale scores increased from 20.7±3.5 [20.9±3.0] to 24.6±2.9 [25.2±2.5] points in the Prospecta group and from 21.7±2.4 [21.6±2.4] to 24.5±3.0 [24.8±2.8] points in the PL group (p=0.0006 [p=0.0014]). 42 adverse events (AEs) were recorded in 32 (26.0%) patients in the Prospecta group and 37 AEs in 28 (23.0%) patients in the PL group (p=0.656). All AEs in the Prospecta group were not significantly related to the use of the drug. No deaths or recurrent IS were recorded. Conclusion . Prospecta is an effective and safe treatment for CI in patients with carotid IS
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".