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Lemborexant for Alzheimer's Disease Biomarkers

This study is looking at whether the sleep medication lemborexant can help reduce certain proteins in the blood that are linked to Alzheimer's disease. Specifically, researchers want to see if lemborexant (at 10 mg or 20 mg doses) can lower the ratio of phosphorylated tau-181/tau-181 (pT181/T181) compared to a placebo (an inactive pill). You might be able to join if you are 65 years or older, do not have dementia (Global Clinical Dementia Rating of 0), and are willing to undergo study procedures. The study aims to enroll 201 participants. The current recruitment status is unclear.

Study design
This is an interventional study comparing two doses of lemborexant to a placebo. It plans to enroll 201 participants.
What's involved
You would take a capsule once daily for 6 months. The study will measure changes in blood biomarkers at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months, indicating the duration of the intervention.

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NCT06274528

DORA and LP in Alzheimer's Disease Biomarkers

Recruiting
PHASE2Ages 65+InterventionalTreatment
University of Minnesota
~201 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Lemborexant 10 mgLemborexant 20mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo
Measured over 6 months

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's Diseasep-Tau217

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Brendan Lucey, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Chloe Meehan, MA
[email protected]
314-273-0878
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo6 months

    plasma collection