Clinical Trial

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.

Study acronym: Neuro-DORA
Recruiting Phase 2
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Record status
This record was last updated October 3, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are: * Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo * Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo. Participants will: * Take 10mg Lemborexant nightly for two weeks * Take a matching placebo nightly for two weeks * Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-06; most recent amendment 2025-09-29.
Status change: Not Yet Recruiting → Recruiting 2025-03-26
Trial Details
NCT Number NCT06823752
Lead Sponsor Woolcock Institute of Medical Research
Conditions Insomnia
Enrollment 20 participants
Start Date 2025-05-13
Primary Completion 2026-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-03