COMBINED NEUROPSYCHOLOGICAL, NEUROPHYSIOLOGICAL AND PSYCHOPHYSIOLOGICAL ASSESSMENT OF THE EFFECTS OF N-PEP-12 ON NEURORECOVERY IN PATIENTS AFTER ISCHEMIC STROKE
Bibliographic record
Abstract
Background and AimsCognitive impairment is a common consequence of patients with stroke, regardless of severity, with significant implications on quality of life. There is increasing evidence to suggest the disproportionate impairment of executive dysfunction in this patient group. N-Pep-12 is a proprietary, peptide-based agent that has been shown to exert neuroprotective and pro-cognitive effects in experimental studies as well as in earlier clinical studies in patients suffering from age-related cognitive deficits.We explore crude differences registered on various outcome scales between patients treated with N-PEP-12 and the reference (control) group.MethodsDesign: exploratory, prospective, randomized, single-blind, controlled, phase IV.Patient recruitment: stroke ischemic in origin, supratentorial, and radiologically confirmed (CT or MRI), onset between 30-120 days pre-screening, no significant pre-stroke disability, no 3-month history of stroke and age between 18-80.Data Analysis: The first 88 consecutive patients with all three visits available (pre-planned sample N=120) were included in an exploratory analysis of study group differences via means comparison tests and graphs. Pre-planned analysis: The statistical analysis plan for this trial specifies a multidimensional approach to combine full (non-dichotomized) neuropsychological outcome scales, using the Wei-Lachin pooling procedure u2013 to be performed after recruitment completion.ResultsParametric (t-test) and Non-parametric means comparison (Mann Whitney U test) yielded statistically significant differences (p<0.05) between treatment and reference groups for the following outcome scales: Montreal Cognitive Assessment, Hospital Anxiety, and Depression Scale-Anxiety and Depression. Color Trails Test, Digit Span, and Processing Speed Index did not reach significance.DiscussionThe present results suggest a potential for a minor effect of the dietary supplement N-PEP-12 for enhancement of neuro-recovery after acute ischemic stroke. Confirmatory analyses are essential to support this claim. The full pre-planned analysis using combined outcome scales (Wei-Lachin) will showcase the combined, multi-dimensional components of both disease and investigated product. Additional sources of bias include lax time-from-stroke inclusion criterion (1-4 months), lack of stratification based on the severity of the stroke and variable baseline heterogeneity. u200bIf confirmed in the final, pre-planned analysis, a potentially positive effect must be replicated in larger, multi-center trials with comparable approaches.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".