Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a common sleep drug fight Alzheimer's? new trial aims to find out

NCT ID NCT06274528

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests whether the sleep medication lemborexant (Dayvigo) can reduce levels of amyloid-beta and tau proteins in the blood and spinal fluid of older adults. These proteins are linked to Alzheimer's disease. The trial will enroll 201 healthy volunteers aged 65 and older, giving them either lemborexant or a placebo for six months to measure changes in these biomarkers.

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 it works, this could point toward a way to slow Alzheimer's by improving sleep and reducing harmful brain proteins.
What could go wrong
This is an early phase 2 trial, so results are not yet proven. The drug may not lower biomarkers enough, and side effects are possible.

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 201 people

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

Started

Mar 2024

Expected to finish

Mar 2030

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

65 years and older

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: * Male or female. * Any race or ethnicity. * Participants must be age ≥ 65 years and able to sign informed consent. * Global Clinical Dementia Rating (CDR) 0. * Willing and able to undergo study procedures. Exclusion Criteria: * History or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia. * STOP-Bang score \>6 for participants without PAP. * Untreated sleep apnea AHI\>15 * Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10. \- PAP compliance is defined as ≥ 4 hours per night \>70% of the nights. * Plasma p-Tau217/np-Tau217% \<2.5 * Stroke. * History of renal impairment * Defined as older adult patients with markers of kidney damage or eGFR \< 45.0 ml/min/1.73m2. * Normal Limits ≥ 45.0 mL/min/1.73m2 * History of hepatic impairment * AST and/or ALT ≥ 2X upper limit of normal (ULN). * Normal Limits: AST 11-47 IU/L and ALT 6-53 IU/L * HIV/AIDS. * History of substance abuse or alcohol abuse in the preceding 6 months. * Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded. * History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate. * Has any medical condition that, in the PI's or study team investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data. Potential medical conditions that will be exclusionary at the PI's or study team investigator's discretion: * Cardiovascular disease requiring medication except for controlled hypertension. * Pulmonary disease. * Type I diabetes. * Neurologic or psychiatric disorder requiring medication. * Untreated depression * Tobacco use. * Use of sedating medications. * Use of medications that interact with lemborexant (if cannot be discontinued). * Abnormal safety labs. * History of current suicidal ideations. * Inability to speak and understand English. * Currently pregnant or breast-feeding. * In the opinion of the PI, the participant should be excluded due to an abnormal physical examination. * Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment. * Must not participate in another drug or device study prior to the end of this study participation. Optional assessment exclusion criteria: • Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.

Vår säkerhetsrekommendation!

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.

  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

  • Washington University in St. Louis, School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.