DORA and LP in Alzheimer's Disease Biomarkers
Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers
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 aid lemborexant can lower amyloid-beta and tau in the blood. These proteins play a role in Alzheimer's disease. The study is for adults age 65 or older with no signs of dementia on a study rating scale.
The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.
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 and 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 procedures.
- Men and women of any race or ethnicity may join.
Who can't join
- Certain sleep problems, such as restless legs, narcolepsy (sudden sleep attacks), or unusual actions during sleep. Sleep apnea (pauses in breathing during sleep) that is untreated or poorly treated, or a high screening score without breathing-machine treatment, can also exclude you.
- A blood tau test result below the study cutoff (p-Tau217/np-Tau217% below 2.5), a stroke, kidney damage or low kidney function, liver problems based on blood tests, or HIV/AIDS.
- 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, unless you agree to cut back.
- Health problems, mental health conditions, past surgery, abnormal tests or exam findings, or medicines that could make the study unsafe or affect results. Examples include certain heart or lung diseases, type 1 diabetes, untreated depression, tobacco use, medicines that cause sleepiness, or medicines that interact with lemborexant and cannot be stopped.
- Current or past thoughts of suicide, inability to speak and understand English, pregnancy, or breastfeeding.
- Being in a drug or device trial within 30 days before joining, or joining another drug or device study before this study ends.
- For the optional spinal tap only: blood-thinning medicines, 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 or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia. * STOP-Bang score \>6 for participants without PAP. * Untreated sleep apnea AHI\>15 * Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10. \- PAP compliance is defined as ≥ 4 hours per night \>70% of the nights. * Plasma p-Tau217/np-Tau217% \<2.5 * Stroke. * History of renal impairment * Defined as older adult patients with markers of kidney damage or eGFR \< 45.0 ml/min/1.73m2. * Normal Limits ≥ 45.0 mL/min/1.73m2 * History of hepatic impairment * AST and/or ALT ≥ 2X upper limit of normal (ULN). * Normal Limits: AST 11-47 IU/L and ALT 6-53 IU/L * HIV/AIDS. * History of substance abuse or alcohol abuse in the preceding 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 or study team investigator'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 or study team investigator's discretion: * Cardiovascular disease requiring medication except for controlled hypertension. * Pulmonary disease. * Type I diabetes. * Neurologic or psychiatric disorder requiring medication. * Untreated depression * Tobacco use. * Use of sedating medications. * Use of medications that interact with lemborexant (if cannot be discontinued). * Abnormal safety labs. * History of current suicidal ideations. * Inability to speak and understand English. * 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. Optional assessment exclusion criteria: • Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).
Study sites (1)
MO
- Washington University in St. Louis, School of Medicine · St Louis, MO 63110Cristina Toedebusch, BS · Study contact · 314-747-0646 · toedebuschc@wustl.eduChloe Meehan, BS, MA · Study contact · 314-273-0878 · cmeehan@wustl.eduBrendan P. Lucey, M.D. · Principal investigatorJ. Philip Miller, Ph.D. · Sub-investigatorMore trials in St Louis