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 cases） 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 treatment， the observation group was better than the control group， with statistical significance （P＜0.05）. There was no statistical difference 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.