Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
120 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for older adults who are healthy and can give consent to test a sleep aid called suvorexant. Participants will help researchers see if this treatment can reduce build-up in the brain related to Alzheimer's disease.
Are You a Good Fit for This Trial?
Rules you outChronic kidney diseaseHepatic impairmentSubstance abuse
You may be able to join if
I am 65 years or older.
I can give my consent to participate.
I am healthy and have a Global Clinical Dementia Rating of 0.
I am willing to follow study procedures.
You may not be able to join if
I have symptoms of restless legs syndrome or narcolepsy.
I have untreated sleep apnea that is severe.
I have had a stroke.
I have chronic kidney disease.
I have liver problems.
I have a history of substance or alcohol abuse in the last 6 months.
I am currently pregnant or breastfeeding.
I have participated in another clinical trial in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 restle…
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).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.