Clinical trial of donepezil in the treatment of patients with AD induced mild cognitive impairment
Objective To explore the effectiveness of donepezil in the treatment of patients with Alzheimer's disease(AD)induced mild cognitive impairment(MCI).Methods Patients with AD-derived MCI were divided into treatment group and control group.The control group received multi-domain cognitive function training,5 times a week for 1 h each time;the treatment group was treated with donepezil hydrochloride tablets at the initial dose of 5 mg·d-1,qd,for 6 weeks.After 6 weeks,it was increased to 10 mg·d-1,qd,and taken until the 12th month.The clinical efficacy of the two groups was compared;and the cognitive function of the patients was evaluated[mini mental state examination(MMSE),Alzheimer's Disease Assessment scale-Cognitive Subscale(ADAS-Cog),California verbal-learning test(CVLT)].Hippocampal volume was calculated;and the rate of hippocampal atrophy was calculated;the number of cases progressing to AD during treatment was counted;and the safety was evaluated.Results Finally,53 cases and 47 cases were included in the treatment group and the control group,respectively.After treatment,the total effective rates of the treatment group and the control group were 62.26％(33 cases/53 cases)and 55.32％(26 cases/47 cases),without statistically significant difference(P＞0.05).After 12 months of treatment,the MMSE scores of the treatment group and the control group were 25.84±2.21 and 26.07±2.18;the ADAS-Cog scores were(11.69±2.36)and(11.75±2.24)point;the quantity of short-term free memories in the CVLT were 13.01±2.04 and 12.78±1.98.The differences between two groups were not statistically significant(all P＞0.05).After 12 months of treatment,hippocampal atrophy rates in the treatment group and the control group were(1.86±0.38)％and(3.34±0.34)％;the incidence rates of progression to AD were 0(0 cases/53 cases)and 8.51％(4 cases/47 cases).The differences were statistically significant(all P＜0.05).Adverse drug reactions of the treatment group mainly included nausea and headache but no adverse drug reaction was observed in the control group.The total incidence rates of adverse drug reactions in the treatment group and the control group were 5.66％(3 cases/53 cases)and 0(0 cases/47 cases),without statistically significant difference(P＞0.05).Conclusion Donepezil has no significant improvement effect on cognitive function in patients with AD induced MCI,but it can reduce the rate of hippocampal atrophy and delay the progression of AD.
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