NCT06093126 · Phase 4 · RECRUITING
Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
This trial tests lemborexant, a newer sleep medication, in a single patient with early-onset dementia and insomnia. Unlike older sleep drugs, it is designed to block wake-promoting brain signals without causing falls, cognitive fog, or rebound insomnia. An N-of-1 trial means the same patient cycles through drug and no-drug periods — it is a Phase 4 study, meaning the drug is already approved but researchers are learning how it works in this specific population.
You may qualify if
- Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.
You're excluded if
- Known sleep disorders that are contraindications for orexin antagonist therapy.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-21