Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers
Washington University School of Medicine
Summary
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.
Description
The overall goal of this project is to conduct an early stage (phase II) clinical trial of a dual orexin receptor antagonist (DORA), lemborexant, in cognitively normal older adults with amyloid deposition to demonstrate the feasibility and potential biological effectiveness of lemborexant's target engagement with multiple blood plasma and cerebrospinal fluid (CSF) Alzheimer's disease (AD) biomarkers. Orexins (also called hypocretins) are wake-promoting neuropeptides and blockade of orexin with a DORA increases sleep. The scientific premise of this project is that increased or enhanced sleep ov…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- Yes
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%…
Interventions
- DrugLemborexant 10 mg
Within FDA approved dose 10 mg; capsule; QD, 6 month duration
- DrugLemborexant 20mg
20 mg; capsule; QD; 6 month duration
- DrugPlacebo
0 mg; capsule; QD; 6 month duration
Location
- Washington University in St. Louis, School of MedicineSt Louis, Missouri