NCT03001557

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irregular Sleep-Wake Rhythm Disorder

Interventions

Type	Name	Description
DRUG	Lemborexant 2.5 mg	Lemborexant 2.5 mg tablets
DRUG	Lemborexant 5 mg	Lemborexant 5 mg tablets
DRUG	Lemborexant 10 mg	Lemborexant 10 mg tablets
DRUG	Lemborexant 15 mg	Lemborexant 5 mg and 10 mg tablets
DRUG	Lemborexant-matched placebo	Lemborexant-matched placebo tablets

Timeline

• Start date: 2016-12-20
• Primary completion: 2018-07-26
• Completion: 2020-04-17
• First posted: 2016-12-23
• Last updated: 2021-05-17
• Results posted: 2020-01-14

Locations

48 sites across 3 countries: United States, Japan, United Kingdom

Regulatory

• FDA-regulated drug study