Actively Recruiting
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
Led by Woolcock Institute of Medical Research · Updated on 2025-10-03
20
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of insomnia disorder by DSM-5 with sleep difficulty at least 3 nights per week for 3 months and daytime impairment
- Insomnia Severity Index (ISI) score of 15 or higher
- Able to provide informed electronic consent
- Fluent in English
- Adults aged 40 to 65 years
You will not qualify if you...
- Highly dependent on medical care as determined by a medical officer
- Untreated moderate to severe sleep apnea (oxygen desaturation index >15)
- Circadian disorders, narcolepsy, severe restless legs syndrome, REM sleep behavior disorder, or uncontrolled psychiatric disorders
- History of attempted suicide or current suicidal thoughts
- Cognitive decline with Montreal Cognitive Assessment score 26 or lower
- Regular shift work, jet lag, or travel over 2 hours time difference within past week
- Pregnancy or lactation without contraception
- Participation in another investigational study within 4 weeks
- Use of medications that inhibit or induce CYP3A4 enzymes
- Ongoing use of antipsychotics, certain antiviral or stimulant drugs, or illicit stimulants
- Regular use of hypnotics, sedating medications, psychostimulants, or opioids within specified washout periods
- Use of THC- or CBD-containing products within 14 days prior to study
- Drug or alcohol dependence within past 2 years
- Allergy to lactose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
Research Team
C
Camilla Hoyos, MPH, PhD
CONTACT
R
Rhearne Ryan, HScHons, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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