Efficacy and Safety of Choline Alphoscerate for Amnestic Mild Cognitive Impairment: A Randomized Double-Blind Placebo-Controlled Trial

Abstract Background Effective interventions for overall healthy subjects with mild cognitive impairment are currently limited. Choline alphoscerate (alpha glyceryl phosphorylcholine, αGPC) is a choline-containing phospholipid used to treat cognitive function impairments in specific neurological conditions. This study aimed to investigate the efficacy and safety of αGPC in individuals diagnosed with mild cognitive impairment. Methods In this multicenter, randomized, placebo-controlled trial, 100 study subjects with mild cognitive impairment underwent double-blind a 727 mg SHCog™ soft capsule (equivalent to 600 mg aGPC) or placebo treatment for 12 weeks. The primary efficacy outcome included changes from baseline on the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog). Safety assessments included regular monitoring of adverse events, and clinical laboratory tests were conducted at baseline and the end of the trial. Results After 12 weeks of αGPC treatment, the ADAS-Cog score decreased by 2.34 points, which was significantly greater than the change observed in the placebo group. No serious AEs were reported, and no study subjects discontinued the intervention because of AEs. There was no significant difference in incidence rate of AEs between the αGPC group and the placebo group. Conclusion This study suggests that αGPC is a safe and effective intervention for improving cognitive function in study subjects with mild cognitive impairment. Trial registration: Clinical Research Information Service; Osong (Chungcheongbuk-do): Korea Centers for Disease Control and Prevention, Ministry of Health and Welfare (Republic of Korea); KCT0008797; A 12-week, multicenter, randomized, double-blind, placebo-controlled human application study to evaluate the efficacy and safety of SH_CAPK08 on cognitive function improvement in mild cognitive decline.