Actively Recruiting

Phase 2
Age: 65Years +
All Genders
Healthy Volunteers
NCT06274528

DORA and LP in Alzheimer's Disease Biomarkers

Led by Washington University School of Medicine · Updated on 2026-05-05

201

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

DORA and LP in Alzheimer's Disease Biomarkers

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • History or symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia.
  • STOP-Bang score greater than 6 for participants without PAP.
  • Untreated sleep apnea with Apnea-Hypopnea Index (AHI) greater than 15.
  • Poorly treated sleep apnea due to noncompliance or an AHI greater or equal to 10.
  • Plasma p-Tau217/np-Tau217% less than 2.5.
  • History of stroke.
  • History of renal impairment defined as eGFR less than 45.0 ml/min/1.73m2.
  • History of hepatic impairment with AST and/or ALT 2 times above upper limit of normal.
  • HIV/AIDS.
  • History of substance or alcohol abuse in the past 6 months.
  • Regular alcohol consumption 3 or more days a week over the last 6 months.
  • Any significant medical, behavioral, or psychiatric condition or surgical history that could affect safety or study assessments.
  • Medical conditions increasing risk or limiting tolerance to procedures, including cardiovascular disease (except controlled hypertension), pulmonary disease, type I diabetes, neurologic or psychiatric disorders requiring medication, untreated depression, tobacco use, sedating medications, or medications interacting 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.
  • Abnormal physical examination as judged by the Principal Investigator.
  • Participation in another clinical trial involving a study drug or device within 30 days prior to enrollment.
  • Participation in another drug or device study prior to completion of this study.
  • Contraindications to lumbar puncture such as anticoagulant use, bleeding disorders, allergies to lidocaine or disinfectant, or prior CNS or lower back surgery.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

C

Chloe Meehan, MA

CONTACT

C

Crirstina Toedebusch

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here