Melatonin for Sleep Improvement in Alzheimer's Disease

This study focuses on sleep problems in people with Alzheimer's disease, a common issue that affects 45% of patients. The goal is to find a solution to these nighttime awakenings and agitation, which often cause significant stress for caregivers and can lead to the decision of nursing home placement. The study is testing the effectiveness of melatonin, a natural hormone that regulates sleep, in improving sleep patterns in 150 Alzheimer's patients living in the community. The importance of this research lies in its potential to improve care for Alzheimer's patients and their caregivers by addressing this common and distressing symptom. The study is designed as a clinical trial, where participants will receive either a placebo or one of two doses of melatonin: a 2.5 mg slow-release or a 10 mg immediate-release preparation. The treatment period will last for 8 weeks. Sleep patterns will be monitored using wrist activity trackers, and the primary outcome being measured is the change in nighttime sleep duration from the start to the end of the treatment phase. Other aspects such as time awake after sleep onset, sleep latency, sleep efficiency, daytime agitation, and changes in cognition will also be evaluated. The safety of melatonin will be assessed by comparing any adverse events or side effects across the treatment groups.