A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild-moderate dementia.

Background: Patients with dementia may suffer from poor sleep quality as well as insomnia and sleep-wake cycle alterations.

Objectives: The main objective of this study was to evaluate the efficacy of melatonin in improving sleep quality.

Methods: This was a single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations (according to Diagnostic and Statistical Manual V criteria) from January 2016 to December 2016.