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Could a sleep pill ward off Alzheimer's? new trial aims to find out

NCT ID NCT07213349

Prevention Sponsor: Douglas Mental Health University Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether daridorexant, a sleep medication, can help the brain clear proteins linked to Alzheimer's disease. The trial includes 240 adults without dementia, regardless of sleep issues. Participants take the drug or a placebo nightly for one year, and researchers measure changes in Alzheimer's-related proteins in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
daridorexant (a sleep medication)
What this could lead to
If successful, this could point toward a new way to prevent Alzheimer's disease by improving brain waste clearance during sleep.
What could go wrong
This is an early phase 2 trial with only 240 participants, so results may not apply broadly. The study measures biological markers, not actual prevention of dementia, and the drug may not show a meaningful effect.

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 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

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

50 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Without dementia as determined by: MoCA \>21 or MMSE \> 24 or Clinical Dementia Rating \<1 * Minimum of 6 years of formal education * Stable psychoactive medication for 1 month prior to screening with no intention to change dose during treatment period * Capacity to provide written consent in English or French Exclusion Criteria: * Clinical diagnosis of major neurocognitive disorder * Unstable psychiatric condition: * Clinically significant active suicidal ideations * Unstable medical condition in the opinion of the investigator. * Known or suspected history of drug or alcohol dependence or abuse within one year of the screening visit * Currently taking a DORA * Allergy or significant adverse reaction to DORA * Use of benzodiazepines or z-drugs \> 2 times per week in the last month. * Use of major and moderate CYP3A4 inducers and inhibitors * Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants. * Active use of cholinesterase inhibitors or memantine * Women who are breast feeding or pregnant * Severe obstructive sleep apnea (OSA)\* * Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia; * Diagnosis of narcolepsy

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Pick disease Alzheimer disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease (AD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)

    RECRUITING

    Montreal, Quebec, H4H 1R3, Canada

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