Sleep Trial to Prevent Alzheimer's Disease
This study is investigating if the sleep medication suvorexant (20 mg) can help prevent Alzheimer's disease by slowing down the accumulation of a protein called amyloid-beta (Aβ) in the brain. Amyloid-beta is linked to the development of Alzheimer's. You may be able to join if you are 65 years or older, do not have dementia (Global Clinical Dementia Rating of 0), and do not have certain sleep disorders like restless legs syndrome. The study will compare the change in amyloid-beta levels in your blood after 18-24 months of taking suvorexant versus a placebo (an inactive substance). The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 120 participants. It will compare the effects of suvorexant to a placebo.
- What's involved
- You would take either suvorexant 20 mg or a placebo nightly for 24 months. Specific details about visits or other procedures are not specified.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 18-24 months, indicating follow-up during this period.
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NCT04629547
Sleep Trial to Prevent Alzheimer's Disease
Recruiting
PHASE2Ages 65+InterventionalPreventionUniversity of MinnesotaInvestigator-initiated
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Suvorexant 20 mgPlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo
Measured over 18-24 months
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Brendan Lucey, MD · PRINCIPAL_INVESTIGATOR · Washington Univeristy School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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 of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia
STOP-Bang score \>6 for participants without PAP
Untreated OSA with AHI ≥15 on home sleep test
Treated sleep apnea with PAP non-compliance
PAP compliance is defined as \>= 4 hours per night \>70% of the nights
Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19
Stroke.
Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \< 45 ml/min/1.73m2.
Hepatic impairment defined as AST and/or ALT \> 2x upper limit of normal (normal limits AST: 11-47 IU/L, ALT: 6-53 IU/L).
HIV/AIDS.
History of substance abuse or alcohol abuse in the proceeding 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 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 discretion:
Cardiovascular disease requiring medication except for controlled hypertension.
Pulmonary disease.
Type I diabetes.
Neurologic or psychiatric disorder requiring medication.
Tobacco use.
Use of sedating medications.
Use of medications that interact with suvorexant (if cannot be discontinued)
Abnormal safety labs
History of current suicidal ideations.
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.
• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).
What this trial measures
- Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo18-24 months
Blood collection