Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2022-05-25
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Poor sleep treatment group
100 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months
Suvorexant 20 mg
Suvorexant 20mg will be taken nightly for 24 months.
Poor sleep control grop
100 participants will be randomized to take placebo daily at h.s. for 18-24 months
Placebo
Placebo will be taken nightly for 24 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Suvorexant 20 mg
Suvorexant 20mg will be taken nightly for 24 months.
Placebo
Placebo will be taken nightly for 24 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Good Ventures
UNKNOWN
Merck Sharp & Dohme LLC
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brendan Lucey
Principal Investigator, Sleep Medicine Section Head
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brendan Lucey, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Univeristy School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202008007
Identifier Type: -
Identifier Source: org_study_id