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lemborexant for 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Treatment Details

Study Objectives

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

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
258 Previous Clinical Trials
83,853 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this research trial?

"The details provided on clinicaltrials.gov indicate that this research study is presently seeking individuals to participate. Initially shared on December 11, 2023, the trial received its latest update on February 12, 2024. A single participant is sought from a sole location for this investigation."

Answered by AI

What risks are associated with the use of lemborexant in individuals?

"Given that this trial is categorized as Phase 4 and lemborexant has already secured approval, it was rated with a safety score of 3 by the Power team."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
Shanna Trenaman 2023. "Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06093126.
All > Semantic Dementia > Frontotemporal Dementia
~1 spots leftby Dec 2028
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