Testing a sleep medicine's effect on brain-health blood markers in insomnia
Tests lemborexant against placebo in adults with insomnia, checking blood markers of brain health.
Plain-language title generated from the registry record
Registry title: A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
Key facts
- Where
- Macquarie Park, AustraliaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 65 with insomnia disorder. Each person takes lemborexant 10mg and a placebo for two weeks each.
- Age
- 40 to 65 years
- Sex
- All sexes can join
- Disease stage
- Insomnia disorder as defined by the DSM-5, with an ISI score of 15 or more
- Earlier treatment
- No regular use of sleep aids, sedating medicines, stimulants, opioids or THC/CBD products within 14 days or 4-5 half-lives before the trial; no recent start or change of antidepressants
Main reasons for not taking part
- Untreated moderate-severe sleep apnoea
- Circadian disorders, narcolepsy, severe restless legs syndrome, REM sleep behaviour disorder or uncontrolled psychiatric disorders
- Past suicide attempt or current suicidal thoughts
- MoCA score of 26 or less
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Source: NCT06823752, who can take part
Where in Australia
- Woolcock Institute of Medical ResearchMacquarie Park, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Woolcock Institute of Medical Research
- Trial code
- NCT06823752
- Record updated
- 18 September 2026
- Original description
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:Read full original descriptionShow less
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia Disorder: a Randomised Placebo-controlled Cross-over Study.
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).
Inclusion: Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI; Able to provide informed electronic consent; Fluent English literacy; Adults aged between 40-65 years.
Exclusion: Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation; Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment; Concomitant use of medicines that are inhibitors (e.g., diltiazem, fluvoxamine, fluconazole, itraconazole, verapamil), or moderate to strong inducers of CYP3A4 (e.g., carbamazepine, modafinil, phenytoin, rifampicin, St John's Wort); Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants; Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial; Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year; Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial; Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period); Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders; History of attempted suicide or current suicide ideation (indicated by a score >0 on Q9 of the Patient Health Questionnaire-9) at pre-screening; Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures; Allergy to lactose; People highly dependent on medical care as determined by a medical officer; Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index>15, ongoing effectively treated sleep apnoea with insomnia will be allowed); Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA); Pregnancy or lactation. Women will be advised to use contraception for the duration of the study and a urine pregnancy test will be performed when necessary; Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial; Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.