RecruitingPhase 2NCT06274528

DORA and LP in Alzheimer's Disease Biomarkers

Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers


Sponsor

Washington University School of Medicine

Enrollment

201 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sleep medication called lemborexant (a type of medication called a DORA) can reduce early Alzheimer's disease markers in the brain and spinal fluid. Researchers believe improving deep sleep may help clear harmful proteins linked to Alzheimer's. **You may be eligible if...** - You are 65 years or older - You have no signs of memory problems or dementia (normal cognitive function) - You are willing to undergo study procedures including possible spinal fluid collection **You may NOT be eligible if...** - You have restless legs syndrome, narcolepsy, or sleep behavior disorders - You have untreated or poorly treated sleep apnea - You have had a stroke, kidney disease, liver disease, or HIV - You have a history of substance or alcohol abuse in the past 6 months - You drink alcohol regularly (3+ days per week) near bedtime - You are pregnant or breastfeeding - You are currently taking medications that interact with the study drug and cannot stop them Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLemborexant 10 mg

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

DRUGLemborexant 20mg

20 mg; capsule; QD; 6 month duration

DRUGPlacebo

0 mg; capsule; QD; 6 month duration


Locations(1)

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT06274528


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