Recruiting
Phase 2

Lemborexant

Sponsor:

University of Minnesota

Code:

NCT06274528

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Lemborexant 10 mg

Lemborexant 20mg

Placebo

Study Details

Brief summary:

The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.

Conditions

Alzheimer Disease

Study ID

NCT06274528

Start date

Mar 11, 2024

Status verified date

Jul, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lemborexant 10 mg

Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

experimental: Lemborexant 20 mg

Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

placebo comparator: Placebo

Placebo is in capsule form and contains an inactive substance. It is taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

Interventions

Lemborexant 10 mg

Within FDA approved dose 10 mg; capsule; QD, 6 month duration

Lemborexant 20mg

20 mg; capsule; QD; 6 month duration

Placebo

0 mg; capsule; QD; 6 month duration

Primary outcome measure

  • Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Washington University in St. Louis, School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Cristina Toedebusch, BS

314-747-0646toedebuschc@wustl.edu

Chloe Meehan, BS, MA

314-273-0878cmeehan@wustl.edu

Principal Investigator:

Brendan P. Lucey, M.D.

More Information

Sponsor

University of Minnesota

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Sleep
  • Older Adults
  • DORA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-13.