Clinical Study on the Neuroprotective Effects of Dengzhan Shengmai Capsule on Brain Structure and Cognitive Function in Patients with Vascular Cognitive Impairment.

Abstract

Introduction: Vascular Cognitive Impairment (VCI) is a common type of dementia that affects the quality of life and lacks effective treatments. The Dengzhan Shengmian capsule (DZSM), a traditional Chinese medicine, is clinically used to alleviate VCI symptoms, but its therapeutic mechanisms are not fully understood. This study aimed to evaluate the neuroprotective effects of DZSM in VCI patients by investigating its impact on cognitive function and brain structure, thereby providing neuroimaging evidence for its clinical application.

Methods: A randomized, double-masked, 6-month trial was conducted with 100 VCI patients, assigned to either the experimental group receiving DZSM (n = 50) or the placebo group (n = 50). The efficacy of DZSM in VCI patients was assessed through cognitive behavioral assessments and neuroimaging data collected at baseline and after 6 months. A comparison was made across groups to determine cognitive and neural changes associated with the intervention.

Results: Participants receiving DZSM exhibited significant improvements across multiple cognitive domains compared to the placebo, including global cognition (MMSE, p = 0.019; ADASCog, p < 0.001), episodic memory (AVLT-N1N5, p < 0.001), visuospatial ability (CDT, p = 0.034), and working memory (DST, p = 0.015). For brain structure, the gray matter volume in the right postcentral and precentral gyrus, bilateral cuneus, left supplementary motor area, superior occipital gyrus, right hippocampus, right thalamus, bilateral lingual gyrus, left precuneus, right inferior frontal gyrus (triangular part), left inferior parietal gyrus, left superior medial frontal gyrus, right superior temporal gyrus, left middle temporal gyrus, and right parahippocampal gyrus increased in the DZSM group (FDR-corrected, p<0.05), with no significant changes in white matter microstructure. Moreover, gray matter volume increases positively correlated with improvements in global cognition and visuospatial function.

Discussion: DZSM capsules significantly improved multiple cognitive domains in VCI patients, particularly memory, visuospatial, and executive functions. The observed increases in gray matter volume suggest that DZSM may exert neuroprotective effects through structural brain remodeling, which is closely associated with cognitive enhancement.

Conclusion: This study identifies brain structural abnormalities in VCI patients that correlate with cognitive deficits. DZSM capsule treatment significantly improved cognitive function. While the underlying mechanisms remain to be fully elucidated, these effects may be related to structural changes in the brain.