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Background

Mild cognitive impairment (MCI), an age-related predementia cognitive disorder, affects the quality of life in the elderly. Currently, there is no effective treatment for preventing or reversing MCI. We developed MMFS-01, a synapse density enhancer, as synapse loss is one of the hallmarks of the aging brain and is strongly associated with the degree of cognitive impairment. In pre-clinical studies we demonstrated MMFS-01 is effective at reversing cognitive deficits in aging and AD model rodents.

Methods

We conducted a randomized, double-blind, placebo-controlled, parallel-designed human clinical trial in elderly subjects (age 50-70) with age-related MCI. Subjects were treated with MMFS-01 (n= 23) or placebo (n= 21) for 12 weeks and their cognitive ability, emotion, sleep quality, and physiological changes were evaluated at baseline, Week 6, and Week 12. Overall cognitive ability was determined by a …