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New treatment option for Sleep
Official title Sleep Trial to Prevent Alzheimer's Disease
ClinicalTrials.gov ID: NCT04629547
What this study is testing
What is Suvorexant 20 mg?
Suvorexant 20 mg is an investigational medicine, being studied as a potential treatment for sleep.
Also referred to as Belsomra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.