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

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.