RECRUITING

DORA and LP in Alzheimer's Disease Biomarkers

Conditions

Alzheimer Disease Sleep Older Adults DORA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-11

Study Completion:2029-03-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06274528

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.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Chloe Meehan, MA

CONTACT

314-273-0878

cmeehan@wustl.edu

Crirstina Toedebusch

CONTACT

314-747-0646

toedebuschc@wustl.edu

Principal Investigator

Brendan Lucey, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University in St. Louis, School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11

Study Completion Date2029-03-11

Study Record Updates

Study Start Date2024-03-11

Study Completion Date2029-03-11

Terms related to this study

Keywords Provided by Researchers

Sleep
Older Adults
DORA

Additional Relevant MeSH Terms

Alzheimer Disease