Actively Recruiting

Phase 2
Age: 65Years +
All Genders
Healthy Volunteers
NCT04629547

Sleep Trial to Prevent Alzheimer's Disease

Led by Washington University School of Medicine · Updated on 2025-12-17

200

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

G

Good Ventures

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.

CONDITIONS

Official Title

Sleep Trial to Prevent Alzheimer's Disease

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female.
  • Any race or ethnicity.
  • Age 65 years or older.
  • Able to sign informed consent.
  • Global Clinical Dementia Rating (CDR) of 0.
  • Willing and able to undergo study procedures.
Not Eligible

You will not qualify if you...

  • History of restless legs syndrome, narcolepsy, other central hypersomnolence disorders, or parasomnia.
  • STOP-Bang score greater than 6 for participants without positive airway pressure (PAP) treatment.
  • Untreated obstructive sleep apnea with apnea-hypopnea index (AHI) of 15 or higher on home sleep test.
  • Non-compliance with PAP treatment (less than 4 hours per night on more than 30% of nights).
  • Plasma amyloid-beta and tau test with plasma p-tau 217% less than or equal to 1.19.
  • History of stroke.
  • Chronic kidney disease with markers of kidney damage or estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2.
  • Liver impairment with AST and/or ALT levels more than twice the upper limit of normal.
  • HIV/AIDS.
  • History of substance or alcohol abuse in the past 6 months.
  • Regular alcohol use 3 or more days a week in the last 6 months, defined as more than 2 drinks within 3 hours of bedtime (unless willing to reduce).
  • Clinically significant medical, behavioral, or psychiatric conditions or surgical history affecting safety or study assessments.
  • Medical conditions increasing risk, limiting tolerance to procedures, or interfering with data collection, including cardiovascular disease requiring medication (except controlled hypertension), pulmonary disease, type I diabetes, neurologic or psychiatric disorder requiring medication, tobacco use, use of sedating medications, or medications interacting with suvorexant that cannot be stopped.
  • Abnormal safety laboratory results.
  • Current suicidal thoughts.
  • Pregnant or breastfeeding.
  • Abnormal physical examination deemed exclusionary by the principal investigator.
  • Participation in another drug or device clinical trial within 30 days prior to enrollment or during this study.
  • Contraindications to lumbar puncture for optional procedures (e.g., anticoagulants, bleeding disorders, allergies, prior central nervous system or lower back surgery).

AI-Screening

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

C

Cristina Toedebusch, BS

CONTACT

C

Chloe Meehan, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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