Study On Sodium Oligomannate Improving Cognitive Function Of Alzheimer’s Disease

Background: Alzheimer’s disease(AD)is an irreversible neurodegenerative disease,which urgently needs new treatments.Sodium oligomannate(GV-971)is an oligosaccharide of marine origin.It can correct intestinal dysbiosis of the gut microbiota,inhibit neuroinflammation and delay AD pathologic cascade reaction.A phase III clinical trial of GV-971 has been completed in China and GV-971 has been proved to improve cognitive function.Objective: To explore the improvement and safety of GV-971 in cognitive function and neuropsychiatric symptoms of AD patients compared with conventional anti AD drugs(Donepezil).Methods: Appropriate AD patients were included in the study through appropriate inclusion and exclusion conditions.65 AD patients included in the study were divided randomly into conventional drug(Donepezil)treatment group and GV-971 group.Adverse reactions were monitored by blood and biochemical check.After 12 weeks of follow-up,the Mini Mental State Scale(MMSE)and Neuropsychiatric Inventory(NPI)of the two groups were evaluated again,the results are obtained through data analysis by SPSS.Results: There was 65 AD patients participated in this study,including 32 patients in the conventional drug(Donepezil)treatment group and 33 patients in the GV-971 group.There was no significant difference in MMSE score,NPI score and population baseline characteristics between the two groups.After 12 weeks of treatment,the MMSE and NPI scores of GV-971 group and conventional drug(Donepezil)group were significantly different from the baseline data(P < 0.05).However,there was no significant difference in MMSE scores between groups.The difference of NPI score improvement between groups was p=0.035(rank sum test)(P< 0.05).One possible drug-related serious adverse reaction occurred in both GV-971 group and conventional drug group.Conclusion: This trial showed that before and after treatment,GV-971 and Donepezil could improve the MMSE and NPI scores of patients.However,there was no significant statistical difference between the groups with improved scores,and it could not be concluded that GV-971 was better than Donepezil in improving cognitive function and neuropsychiatric symptoms(NPS)in patients with Alzheimer’s disease.