Recruiting
Phase 2

Suvorexant with Medication

Sponsor:

University of Minnesota

Code:

NCT04629547

Conditions

Sleep

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Suvorexant 20 mg

Placebo

Study Details

Brief summary:

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

Sleep

Alzheimer Disease

Study ID

NCT04629547

Start date

May 25, 2022

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

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 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.

Exclusion criteria for optional lumbar punctures

-• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Poor sleep treatment group

60 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months

placebo comparator: Poor sleep control grop

60 participants will be randomized to take placebo daily at h.s. for 18-24 months

Interventions

Suvorexant 20 mg

Suvorexant 20mg will be taken nightly for 24 months.

Placebo

Placebo will be taken nightly for 24 months.

Primary outcome measure

  • Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo [ Time Frame: 18-24 months ]

Central Contacts and Locations

Central contacts

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Cristina Toedebusch, BS

314-747-0646toedebuschc@wustl.edu

Principal Investigator:

Brendan Lucey, MD

More Information

Sponsor

University of Minnesota

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • poor sleep
  • Amyloid-Beta
  • Insomnia

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.