RECRUITING

Sleep Trial to Prevent Alzheimer's Disease

Conditions

Sleep Alzheimer Disease poor sleep Amyloid-Beta Insomnia

Quick Navigation

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 determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.

Official Title

Sleep Trial to Prevent Alzheimer's Disease

Quick Facts

Study Start:2022-05-25

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04629547

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 of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia * Actigraphic sleep efficiency \>85%. * Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways). * 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% ≤0.82 * 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.

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 of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia
* Actigraphic sleep efficiency \>85%.
* Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways).
* 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% ≤0.82
* 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.

Contacts and Locations

Study Contact

Cristina Toedebusch, BS

CONTACT

3147470646

toedebuschc@wustl.edu

Chloe Meehan, MA

CONTACT

3142730878

cmeehan@wustl.edu

Principal Investigator

Brendan Lucey, MD

PRINCIPAL_INVESTIGATOR

Washington Univeristy School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Brendan Lucey, MD, PRINCIPAL_INVESTIGATOR, Washington Univeristy 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 Date2022-05-25

Study Completion Date2026-05

Study Record Updates

Study Start Date2022-05-25

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

poor sleep
Amyloid-Beta
Insomnia

Additional Relevant MeSH Terms

Sleep
Alzheimer Disease