Therapeutic regimen for AD-derived MCI: the effect of sodium oligomannate (GV-971) combined with donepezil on patients’ cognitive function and hippocampal atrophy rate

To investigate the clinical efficacy of sodium oligomannate (GV-971) combined with donepezil in the treatment of patients with mild cognitive impairment (MCI) in Alzheimer’s disease (AD). This non-randomized, open-label, retrospective analytic study included 100 patients with AD-derived MCI who were treated in our hospital between May 2023 and May 2024, and were divided into two groups according to the different treatment modalities recorded in the electronic medical record system: 44 cases in the control group (donepezil), and 56 cases in the observation group (sodium oligomannate (GV-971) combined with donepezil). Cognitive function, biochemical markers (homocysteine (Hcy), S100 calcium binding protein B (S100β), neuron-specific enolase (NSE)), serum intestinal flora metabolic markers (phenylalanine (Phe), short-chain fatty acids (SCFA), γ-aminobutyric acid (GABA), acetylcholine (Ach)), hippocampal volume, and adverse effects were collected and compared between the two groups, and adverse reactions were recorded. After treatment, the comparison of various scores of cognitive function, Hcy, S100β, NSE, Phe, SCFA, GABA, and Ach between the patients in the observation group and the control group showed statistically significant differences ( P <0.05); after treatment, the comparison of left hippocampal volume, right hippocampal volume, and total volume between the observation group and the control group did not show any statistically significant difference ( P >0.05). In contrast, the calculated hippocampal atrophy rate—derived from the percentage change relative to baseline volume—was significantly lower in the observation group than in the control group ( P < 0.05). Regarding safety, the total incidence of adverse reactions was 10.71% (6/56) in the observation group versus 9.09% (4/44) in the control group, with no statistically significant difference between the two groups ( P > 0.05). The combination of sodium oligomannate (GV-971) and donepezil was associated with more favorable changes in cognitive function, neuronal injury biomarkers, serum markers of gut microbiota metabolism, and a slower observed rate of hippocampal atrophy in patients with AD-derived MCI. These associations do not imply causation, and the combination regimen did not significantly increase adverse reactions in this cohort.