Abstract: Objective: To observe the clinical effect of Fufang Haishe capsules combined with galanthamine for earlyonset Alzheimer disease(AD) in the elderly,and its effect on high mobility group protein B1(HMGB1) and cytokines in serum. Methods:A total of 86 cases of patients with early-onset AD were selected and divided into the observation group and the control group according to the random number table method, 43 cases in each group. The control group was treated with galanthamine,and the observation group was additionally treated with Fufang Haishe capsules based on the treatment of the control group. Both groups were treated for three months. The clinical effect was compared between the two groups. The changes in scores of Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog) and Neuropsychiatric Inventory(NPI) were evaluated before and after treatment. The changes in the levels of HMGB1 and cytokines in serum were evaluated before and after treatment. Results:The total effective rate was 93.02% in the observation group,higher than that of 67.44% in the control group, the difference being significant(P<0.05). Before treatment, there was no significant difference in the comparison of ADAS-Cog score and NPI score between the two groups(P>0.05). After treatment,the ADAS-Cog score and NPI score in the two groups were lower than those before treatment(P<0.05),and the two scores in the observation group were lower than those in the control group(P<0.05). Before treatment, when compared the levels of HMGB1, TNF- α, IL- 1 and IL- 6 in serum between the two groups,there was no significance in differences(P>0.05). After treatment,the levels of HMGB1,TNF-α,IL-1 and IL-6 in serum the two groups were lower than those before treatment,and the levels above in the observation group were lower than those in the control group, differences being significant(P<0.05). Conclusion:The therapy of Fufang Haishe capsules combined with galanthamine has good clinical effect in the treatment of early-onset AD in the elderly,which can reduce the expression of HMGB1 and levels of TNF-α,IL-1 and IL-6.