Could a common sleep drug fight Alzheimer's? new trial aims to find out
NCT ID NCT06274528
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 201 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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).
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Washington University in St. Louis, School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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