OBJECTIVE:To observe clinical efficacy and safety of butylphthalide in the treatment of Alzheimer’s disease (AD). METHODS:94 AD patients selected from our hospital during Jan. 2013-Jun. 2014 were divided into control group(45 cas-es)and observation group(49 cases). Control group was given routine treatment as nourishing nerve,lowering blood lipid,taking Memantine hydrochloride tablet orally 5 mg,bid. Observation group was additionally given Butylphthalide soft capsule orally 0.2 g,tid,on the basis of control group. Both groups were treated for consecutive 1 year. Clinical efficacy of 2 groups were observed, and MMSE,ADL,the levels of TNF-α,IL-1,CRP and BDNF were observed before and after treatment;the incidence of ADR was compared. RESULTS:The total effective rate of observation group was 85.71%,which was significantly higher than that of control group(66.67%),with statistical significance(P<0.05). There was no statistical significance in MMSE and ADL between 2 groups before treatment (P>0.05);those of 2 groups increased significantly after treatment,the observation group was higher than the control group,with statistical significance (P<0.05). There was no statistical significance in the levels of TNF-α,IL-1, CRP and BDNF between 2 groups before treatment(P>0.05). Above indexes of 2 groups were improved significantly after treat-ment,the observation group was better than the control group,with statistical significance(P<0.05). There was no statistical dif-ference in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS:Butylphthalide is effective in the treatment of AD,can improve cognitive and life skills and reduce inflammatory level with good safety.