P075 Feasibility of 12 weeks melatonin supplementation in Mild Cognitive Impairment

Abstract

Abstract Introduction Melatonin has been hypothesised to slow cognitive decline in older adults due to its proposed multiple therapeutic benefits. Methods Participants with Mild Cognitive Impairment (MCI) were recruited from the community for a pilot 12-week randomised placebo-controlled trial of 25mg oral melatonin to target brain oxidative stress and cognition. Primary outcomes were feasibility, acceptability, and tolerability. Secondary outcomes were brain oxidative stress (magnetic resonance spectroscopy) and cognition at 12 weeks. Results The study recruited 40 participants who were randomised to receive melatonin or placebo. Feasibility of recruitment, calculated by the percent of individuals who met inclusion and exclusion criteria on screening, was 42/389, 11%. The most common exclusion criteria met was age. Acceptability of intervention, defined as the number of participants who agreed to be randomised, was 40/42, 95%. At 12 weeks, adherence data collected by both medication diaries and pill counting was over the 80% threshold for all participants. Additionally, 38 participants completed MRI scans and 40 participants completed the cognitive assessment battery, providing preliminary data to support future trials. Discussion The results of this feasibility trial demonstrate challenge to find individuals in the general community that fit the criteria for MCI. However, once recruited, this population has shown the ability to follow the protocol and adhere to the trial medication. These results will inform a future definitive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function.