Effects of choline alfoscerate on cognitive function and quality of life in type 2 diabetes: A double‐blind, randomized, placebo‐controlled trial

Abstract Aims This study evaluated the effects of choline alfoscerate on cognitive function and quality of life in T2DM patients with mild cognitive decrements. Materials and Methods In a double‐blind, randomized, placebo‐controlled trial, we recruited 36 individuals with T2DM and mild cognitive impairment which was assessed by the Mini‐Mental State Examination (MMSE) score of 25–28, and randomly assigned them to receive either 1200 mg/day of choline alfoscerate or a placebo. Four additional questionnaires—the 36‐Item Short Form Survey, the modified Informant Questionnaire on Cognitive Decline in the Elderly, the Korean version of Activities of Daily Living, and the Patient Health Questionnaire—were investigated at 6 and 12 months and analysed via mixed‐effects models for repeated measures. Results The mean age of study participants was 71.8 ± 5.3 years and 69.4% women. Six‐month treatment with choline alfoscerate resulted in a non‐significant increase in the MMSE score from 26.2 ± 1.3 to 26.9 ± 2.0, whereas the placebo group showed a non‐significant decline from 26.6 ± 1.3 to 25.9 ± 2.3, resulting in a mean difference of +1.4 between the two groups ( p = 0.059). At 12 months, the mean difference increased to +1.7 with statistical significance ( p < 0.001). Physical health, as measured by the SF‐36 survey, was significantly better in the choline alfoscerate group than in the placebo group. Conclusions Choline alfoscerate 1200 mg once daily treatment showed marginal improvement in cognitive function in T2DM patients with mild cognitive impairment at 6 months but leading to significance at 12 months compared to placebo, suggesting its potential as an adjunct therapy for managing early cognitive decline.