A multicenter randomized controlled study of Anthocyanins for the treatment of Alzheimer's disease / 中华老年医学杂志

ABSTRACT

Objective:To assess the safety and efficacy of Anthocyanins for the treatment of Alzheimer's disease.Methods:From November 2018 to December 2020, a multicenter, double-blind, randomized controlled clinical study was conducted in 6 hospitals.The regular medication for the two groups was memantine, with the addition of a combination preparation containing Anthocyanins for the experimental group and a placebo for the control group.The Mini-Mental State Scale(MMSE), Montreal Cognitive Assessment Scale(MoCA), Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog), Activities of Daily Living Scale(ADCS-ADL)and Hamilton Depression Scale(HAMD)were used for assessment at the beginning.After 16 weeks of treatment, MMSE, MoCA, ADCS-ADL, ADAS-cog and the Clinician's Interview-Based Impression of Change Plus Caregiver Input(CIBIC-Plus)Scale were conducted and adverse events were recorded.Results:A total of 66 patients were enrolled, with 33 in the control group and 33 in the experimental group.There were no significant differences in cognitive function scores between the two groups before enrollment.Differences in MMSE scores, MOCA scores and ADAS-cog scores before and after treatment between the control group and the experimental group were 1.9±2.4 vs.3.4±2.0( t=2.62, P=0.011), 1.8±1.9 vs.2.9±1.4( t=2.45, P=0.018)and 3.0±2.3 vs.5.3±4.6( t=2.45, P=0.019), respectively.The differences were statistically significant.Instrumental activities of daily living(IADL)scores before and after treatment in the control group were 21.6±5.7 vs.22.6±6.2( t= 2.09, P= 0.046), and those in the experimental group were 22.7±5.4 vs.23.4±5.4( t= 2.45, P= 0.021). The differences between the two groups before and after treatment were statistically significant. Conclusions:Treatment with Anthocyanins can delay the decline of cognitive function and activities of daily living ability in patients with Alzheimer's disease.Anthocyanins may be a promising therapeutic drug for Alzheimer's disease in the future.