RecruitingPhase 2

Sleep Trial to Prevent Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the sleep medicine suvorexant can slow the buildup of amyloid-beta, a protein in the brain. It is for adults age 65 or older with no signs of dementia on a standard rating scale.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65 or older.
  • Able to sign a form agreeing to join the study.
  • No signs of dementia on the Clinical Dementia Rating scale (score of 0).
  • Willing and able to complete study tests and procedures.
  • People of any sex, race, or ethnicity may join.

Who can't join

  • Certain sleep problems, such as restless legs, narcolepsy, too much daytime sleepiness, or unusual actions during sleep. Sleep apnea may also exclude you: a STOP-Bang score over 6 without breathing-machine treatment, at least 15 breathing pauses per hour without treatment, or not using the prescribed machine enough.
  • A blood test result called plasma p-tau 217% of 1.19 or lower.
  • Stroke, HIV/AIDS, kidney damage or low kidney function, or liver blood tests more than twice the normal upper limit.
  • Drug or alcohol abuse in the past 6 months. Also, more than 2 alcoholic drinks within 3 hours of bedtime on 3 or more days a week during that time. You may still qualify if you agree to drink less.
  • Health problems, past surgery, or abnormal exams or lab tests that the study doctor thinks could make the study unsafe or affect results. These may include heart or lung disease, type 1 diabetes, brain or mental health conditions needing medicine, tobacco use, medicines that cause sleepiness, or medicines that interact with suvorexant and cannot be stopped.
  • Current thoughts of suicide, pregnancy, or breastfeeding.
  • Taking part in another study of a drug or device within 30 days before joining, or while in this study.
  • For optional spinal taps only: blood-thinning medicine, a bleeding disorder, allergy to lidocaine or disinfectant, or past surgery on the brain, spinal cord, or lower back. A spinal tap collects fluid from the lower back.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

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