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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irregular Sleep-Wake Rhythm Disorder

In brief

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.

Key facts

Study ID: NCT03001557
Run by: Eisai Inc.
People needed: 63
Starts: 2016-12-20
Expected to finish: 2020-04-17
Last updated by the study team: 2021-05-17

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

A diagnosis of vascular dementia, dementia following multiple strokes, or any synucleinopathy / Lewy body disorder. This includes Dementia with Lewy Bodies and Parkinson's disease with or without dementia.
A current diagnosis of moderate to severe obstructive sleep apnea (OSA) or central sleep apnea, or current use of continuous positive airways pressure even if mild severity of OSA, restless legs syndrome, periodic limb movement disorder (with awakenings), or narcolepsy
An Apnea-Hypopnea Index or equivalent ≥15 events/hour on diagnostic sleep study conducted prior to Baseline or within 6 months of Screening
A clinically significant movement disorder that would affect the differentiation of sleep and wake by the actigraphy analytic algorithm
Current symptoms or history during the past year of Rapid Eye Movement Behavior Disorder or sleep-related violent behavior
Probable Major Depression, as evidenced by score >10 on the Cornell Scale for Depression in Dementia at Screening
Unable to tolerate wearing the actigraph. At a minimum, participants must be able to wear the actigraph for 5 complete days out of 7 days' data. A day will be considered complete as long as data from 90% of the 24-hour period are able to be scored.
Excessive caffeine use that in the opinion of the investigator contributes to the participant's Irregular Sleep-Wake Rhythm Disorder (ISWRD)
History of drug or alcohol dependency or abuse within approximately the previous 2 years
Reports habitually consuming more than 14 drinks containing alcohol per week or habitually consumes alcohol within 3 hours before bedtime and unwilling to limit alcohol intake to 2 or fewer drinks per day or forego having alcohol within 3 hours before bedtime for the duration of his/her participation in the study
Known to be human immunodeficiency virus positive
Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
A prolonged QTcF interval (QTcF >450 milliseconds[ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms) (participants with evidence of bundle branch block are not excluded if the block is not clinically significant, as documented by the investigator in the source document)
Current evidence of clinically significant disease that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Any history of a medical or psychiatric condition other than Alzheimer's Disease dementia that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
History of malignancy within the previous 5 years except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ
Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of Screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the electronic version of the Columbia Suicide Severity Rating Scale (eC-SSRS)
Any suicidal behavior within the past 10 years based on the eC-SSRS
History of violence toward the caregiver or others
Scheduled for surgery using general anesthesia during the study
Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half-lives, whichever is longer, before starting actigraphy during Screening
Used any modality of treatment for ISWRD between Screening and Randomization based on approaches related to circadian rhythms, including phototherapy (light therapy), melatonin and melatonin agonists
Failed treatment with Belsomra (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
Transmeridian travel across more than 3 time zones between Screening and Randomization, or plans to travel across more than 3 time zones during the study
Hypersensitivity to lemborexant or to its excipients

Where it is running

Facility #1 — Little Rock, Arkansas, United States
Facility #1 — Rogers, Arkansas, United States
Facility #1 — Costa Mesa, California, United States
Facility #1 — Fullerton, California, United States
Facility #1 — Glendale, California, United States
Facility #1 — Irvine, California, United States
Facility #1 — Irvine, California, United States
Facility #1 — La Jolla, California, United States
Facility #1 — San Diego, California, United States
Facility #1 — Santa Monica, California, United States
Facility #1 — Bradenton, Florida, United States
Facility #1 — Brandon, Florida, United States
Facility #1 — Brooksville, Florida, United States
Facility #1 — Hallandale, Florida, United States
Facility #1 — Miami, Florida, United States
Facility #1 — Miami, Florida, United States
Facility #1 — Miami Lakes, Florida, United States
Facility #1 — Miami Springs, Florida, United States
Facility #1 — Orlando, Florida, United States
Facility #2 — Orlando, Florida, United States
Facility #1 — Sunrise, Florida, United States
Facility #2 — Tampa, Florida, United States
Facility #1 — Atlanta, Georgia, United States
Facility #1 — Columbus, Georgia, United States
Facility #1 — Macon, Georgia, United States

Full record on ClinicalTrials.gov

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