Using Lemborexant to treat insomnia in patients with dementia
Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06093126 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with early-onset dementia who also experience significant insomnia.
Not a fit: Patients with known sleep disorders that contraindicate the use of orexin antagonist therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Halifax, Nova Scotia
- Nova Scotia Health — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Shanna C Trenaman, BScPharm, PhD
- Email: shanna.trenaman@dal.ca
- Phone: 19024310559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.