3‐month melatonin supplementation to reduce brain oxidative stress and improve sleep in mild cognitive impairment: a randomised controlled feasibility trial

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AbstractBackgroundMelatonin has multiple proposed therapeutic benefits including antioxidant properties, circadian rhythm synchronisation and sleep promotion. Since these areas are also recognised risk factors for dementia, melatonin has been hypothesised to slow cognitive decline in older adults.MethodParticipants with Mild Cognitive Impairment (MCI) were recruited from the community for a 12‐week randomised placebo‐controlled parallel, feasibility trial of 25mg oral melatonin daily. Primary outcomes were feasibility, acceptability, and tolerability. Secondary outcomes were brain oxidative stress, cognition, mood, and sleep at 12 weeks.ResultForty participants were randomised to receive melatonin or placebo. Feasibility, determined by the percentage of people who met inclusion and exclusion criteria and could potentially join the study, was 42/389, 11%. The most common reason for exclusion was age. Acceptability, the number of people who agreed to be randomised as a fraction of all potential participants, was 40/42, 95%. Adherence to the intervention and completion of the main secondary outcome (oxidative stress) was over the pre‐defined 80% threshold for all participants and reported safety outcomes were balanced between groups. The current protocol was feasible and acceptable as we reached our target of 40 participants between 60‐80 years of age with MCI. All participants were able to complete all aspects of the trial, including online visits and assessments.ConclusionThis is promising for future trials which should conduct the study with a higher sample size and longer duration to yield necessary efficacy data.