DORA and LP in Alzheimer's Disease Biomarkers

Description

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.

Conditions

Alzheimer Disease

Study Overview

Study Details

Study overview

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.

Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers

DORA and LP in Alzheimer's Disease Biomarkers

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in St. Louis, School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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.
  • * Negative plasma amyloid-beta and tau test
  • * 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.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

Brendan Lucey, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2029-03-11