Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
Status:
Completed
Trial end date:
2020-04-17
Target enrollment:
Participant gender:
Summary
This study will be conducted to determine the dose response of lemborexant (LEM) on the
change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters,
and circadian-rhythm related parameters. Following the eligibility screening period, eligible
participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks.
After a 2-week follow-up period, eligible participants may enter an open-label extension
period for up to 30 months or until the program discontinuation.