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Lemborexant for Insomnia in Dementia

Phase 4
Recruiting
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Known sleep disorders that are contraindications for orexin antagonist therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 8 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is looking at a new medication called lemborexant for treating insomnia. Traditional sleeping aids like benzodiazepines can cause negative side effects like drowsiness and dizziness,

Who is the study for?
This trial is for adults with early-onset dementia, including Alzheimer's and various other forms, who also suffer from significant insomnia. It's not suitable for those with sleep disorders that don't mix well with orexin antagonist therapy.
What is being tested?
The trial tests Lemborexant 5 MG, a new type of sleeping aid less likely to cause side effects like driving impairment or dependence seen in traditional sedatives. It aims to understand its effectiveness and tolerability in individual patients.
What are the potential side effects?
Lemborexant may have fewer side effects compared to traditional sleeping aids. Rarely it can cause drowsiness or dizziness but is generally not associated with severe issues like rebound insomnia or dependency.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have sleep disorders that prevent me from taking orexin antagonist therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of night awakenings
Quality of sleep
Sleep onset latency (SOL)
+2 more
Secondary study objectives
Drop-out due to ADR
Presence & severity of ADRs

Side effects data

From 2020 Phase 3 trial • 53 Patients • NCT04009577
10%
Accidental overdose
5%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2A (Core Study): LEM 5
Cohort 2B (Core Study): LEM 10
Cohort 2A (Core Study): LEM 10
Cohort 1A (Extension Phase): LEM 5
Cohort 2B (Core Study) : LEM 5
Cohort 1B (Core Study): LEM 10
Cohort 1A (Core Study): LEM 5
Cohort 1A (Core Study): LEM 10
Cohort 1B (Core Study): LEM 5
Cohort 1A (Extension Phase): LEM 10
Cohort 1B (Extension Phase): LEM 5
Cohort 1B (Extension Phase): LEM 10
Cohort 2A (Extension Phase): LEM 5
Cohort 2A (Extension Phase): LEM 10
Cohort 2B (Extension Phase): LEM 5
Cohort 2B (Extension Phase): LEM 10

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: lemborexantExperimental Treatment1 Intervention
The study will be an N of 1 trial over 8 weeks were treatment with lemborexant being alternated with a placebo in an "ABBABAAB" format.

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
287 Previous Clinical Trials
94,321 Total Patients Enrolled
~1 spots leftby Dec 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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