Recruiting

SToP-ADSuvorexant for Amyloid-β Reduction in Alzheimer's Prevention

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What is being tested

Suvorexant 20 mg

+ Placebo

Drug
Who is being recruted

Alzheimer Disease+13

+ Mental Disorders

+ Brain Diseases

Over 65 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Study ContactCristina Toedebusch, BSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 25, 2022

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out if the drug suvorexant can help prevent Alzheimer's disease by slowing down the build-up of a protein called amyloid-β in the brain. Amyloid-β is known to play a role in the development of Alzheimer's, which is a progressive brain disorder affecting memory and thinking skills. The study targets individuals who may be at risk of developing Alzheimer's, aiming to find new ways to delay or reduce the onset of this condition. By potentially reducing amyloid-β levels, this study could lead to new preventive treatments, which are currently limited. Participants in the study will receive either a 20 mg dose of suvorexant or a placebo. The treatment is administered orally. The main focus is to measure changes in amyloid-β levels using a blood test that detects specific proteins like pT217/T217. Blood samples are collected to see if there is a difference in amyloid-β accumulation between those taking suvorexant and those receiving a placebo. This helps researchers understand if suvorexant has the potential to slow down the disease process before symptoms appear.

Official TitleSleep Trial to Prevent Alzheimer's Disease
NCT04629547
Principal SponsorWashington University School of Medicine
Study ContactCristina Toedebusch, BSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurocognitive DisordersPathological Conditions, AnatomicalSleep Disorders, IntrinsicDyssomniasTauopathiesPlaque, Amyloid

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Washington University School of Medicine

St Louis, United StatesOpen Washington University School of Medicine in Google Maps
Recruiting
One Study Center