At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
In Brief
A Phase 2 clinical trial evaluating Lemborexant 2.5 mg, Lemborexant 5 mg, and 3 other interventions for Irregular Sleep-Wake Rhythm Disorder. Completed, enrolled 63 participants across 48 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Lemborexant 2.5 mg tablets
Lemborexant 5 mg tablets
Lemborexant 10 mg tablets
Lemborexant 5 mg and 10 mg tablets
Lemborexant-matched placebo tablets