Clinical trial Recruiting at 1 site Phase 4 Interventional

Using Lemborexant to treat insomnia in patients with dementia

Official title: Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

Run by Nova Scotia Health Authority · NCT06093126 · Data updated 2026-11-12

This study is testing if a new sleep medication called lemborexant can help people with early-onset dementia sleep better without causing the usual side effects of other sleep aids.

More Dementia trials

Quick facts

PhasePhase 4
Study typeInterventional
SexAll
Enrollment1 (estimated)
SponsorNova Scotia Health Authority
Academic / other
Locations1 site (Halifax, Nova Scotia)
StatusRecruiting
StartedDecember 11, 2023
Main results expectedDecember 11, 2028
Study endsDecember 11, 2028
Registry record updatedFebruary 21, 2025
Trial IDNCT06093126 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals diagnosed with early-onset dementia who also experience significant insomnia.

Probably not a fit

Patients with known sleep disorders that contraindicate the use of orexin antagonist therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of lemborexant, a dual orexin receptor antagonist, in treating insomnia among patients with early-onset dementia. The study aims to address the challenges of using traditional sleeping aids, which can exacerbate cognitive impairment and other adverse effects in older adults. By focusing on a personalized approach, the trial evaluates how well lemborexant can improve sleep without the common side effects associated with conventional medications. Participants will receive a 5 MG dose of lemborexant to assess its impact on their insomnia symptoms.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing insomnia in patients with dementia.

How similar studies have gone: While lemborexant is a newer treatment, similar approaches using dual orexin receptor antagonists have shown promise in other populations, suggesting potential for success in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.

Exclusion Criteria:

* Known sleep disorders that are contraindications for orexin antagonist therapy.

Where it's running

  • Nova Scotia Health
    Halifax, Nova Scotia, Canada
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.