Study of Melatonin: Sleep Problems in Alzheimer's Disease
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated
with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of
AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for
caregivers. Alternatives are sorely needed to the currently available sleep medications that
have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone
secreted by the pineal gland. It has soporific effects with oral administration and is well
tolerated. It enhances sleep in normal older people. Melatonin also may help sleep
disturbances associated with AD; however, this remains to be proven.