ABSTRACT NUMBER: ESOC2026A895 COGNITIVE AND NEUROPSYCHIATRIC OUTCOMES IN ACUTE STROKE INTERVENTION: A SYSTEMATIC REVIEW OF PHASE 3 TRIALS PROTOCOLS (2014-2024)

Abstract Background and aims Cognitive and neuropsychiatric sequelae following stroke are common yet frequently underrecognized, despite their major impact on functional and quality-of-life outcomes. We conducted a systematic review to quantify how often cognitive and neuropsychiatric outcomes are included as efficacy measures in randomized controlled trials of acute-phase stroke interventions. Methods ClinicalTrials.gov and World Health Organization-recognized registries were searched for interventional phase 3 trials protocols on acute ischemic or hemorrhagic stroke (January 2014-December 2024). Trials were included if the intervention occurred <72 hours of symptom onset. Data extraction was independently performed by two blinded reviewers, and descriptive statistics summarized the outcomes. Quantitative data (number and percentage of the studies employing cognitive outcomes) and qualitative findings (cognitive tools employed) were reported and tabulated. This systematic review followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines and was registered in PROSPERO (CRD420251048699). Results Of 4,424 screened protocols, 572 met inclusion criteria and were included. According to trial protocols, 127 studies (22.2%) planned cognitive and/or neuropsychiatric outcome measures. In all cases except for one study, they were used as secondary outcomes. In 74/127 studies (58.3%), cognitive/neuropsychiatric outcomes were limited to items within non-specific quality-of-life instruments, whereas 53/127 (41.7%) included specific cognitive/neuropsychiatric outcomes. The most frequently used cognitive tools were Montreal Cognitive Assessment (n=26) and Mini-Mental State Examination (n=13), while the most common neuropsychiatric tools were Hamilton Depression Rating Scale (n=7) and Geriatric Depression Scale (n=2). Conclusions Cognitive and neuropsychiatric domains remain underrepresented outcome measures in acute stroke trial intervention protocols. Conflict of interest All authors have nothing to disclose