Randomized,double-blind,placebo-controlled international clinical trial of the Ampakine CX516 in elderly participants with mild cognitive impairment: a progress report

This progress report briefly describes the rationale and study design for the first cross-national clinical study of a positive AMPA-type glutamate receptor modulator in subjects with mild cognitive impairment (MCI). The study medication for the double-blind, placebo-controlled trial, the AMPAKINE CX516, represents a novel pharmacological approach to the treatment of memory disorders. Previous preclinical and pilot clinical studies have shown that CX516 has the ability to enhance memory and cognition. Design of the trial, including outcome measures and inclusion criteria, was aided by an international panel of experts in the newly emerging field of MCI.