Sleep pill may shield brain from Alzheimer's damage
NCT ID NCT06823752
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests whether the insomnia medication lemborexant (Dayvigo) can lower blood markers of brain damage in adults aged 40–65 with insomnia. Twenty participants will take the drug or a placebo for two weeks each, then have their blood tested for proteins linked to Alzheimer's disease. The goal is to see if improving sleep with this drug might protect the brain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lemborexant (Dayvigo)
- What this could lead to
- If successful, this could suggest that treating insomnia with lemborexant may help protect the brain from damage linked to Alzheimer's disease.
- What could go wrong
- This is a very small, early-phase study with only 20 people and a short 2-week treatment. It measures blood markers, not actual disease prevention, so results may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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). * 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. * Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA) * Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation. * 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. * 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. * 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. * 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. * 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. * Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial. * 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). * Allergy to lactose.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Insomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Woolcock Institute of Medical Research
RECRUITINGMacquarie Park, New South Wales, 2113, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Does soreness after exercise disrupt sleep more for people with insomnia?
- Can fixing insomnia help heavy drinkers cut back?
- Can a sleep therapy program help control blood sugar in older diabetes patients?
- Can better sleep cut heavy drinking? therapy tested in veterans