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The Sleep Amyloid, Slow WAve Race and Ethnicity Study

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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

African-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors. To test these hypotheses, the investigators will perform community outreach in churches and community-based organizations in Brooklyn and other NYC boroughs with which we have created substantial ties in recent years. In consultation with community stakeholders, the investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex, BMI, income and education matched non-Hispanic whites from the same geographical areas. Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants will then undergo 2 nights of home sleep monitoring using an unattended device to exclude OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10 hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2).

Official Title

A Single-center, Observational, Longitudinal Study on the Effect of Slow Wave Sleep (SWS) Characteristics and Race and Ethnicity on Amyloid Burden (a Marker of Alzheimer's Disease Risk), Among Cognitively Normal Elderly

Quick Facts

Study Start:2018-11-21

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03814603

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:60 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female subjects with normal cognition and ages 60 to 75. * Within normal limits on neurological and psychiatric examinations. All subjects enrolled will have a CDR=0. * An informed family member or life-partner (preferably bed-partner) will be interviewed over the phone or on the first or second visit to confirm the reliability of the subject interview. A study partner is preferably a spouse, close friend, or relative. * Self-identified as African-American Black or non-Hispanic white. * All subjects must sign the Alzheimer's Disease Center consent form	* History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). * Significant history of alcoholism based off of the CAGE questionnaire (\>2) or drug abuse. * History of psychiatric illness (e.g., schizophrenia, bipolar or PTSD) * Lifelong depression and anxiety will be allowed as long as there has been no active depressive episode within the last two years. * Geriatric Depression Scale (short form)\>6. * Insulin dependent diabetes. * Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions based off of the PI's discretion. * Physical impairment of such severity as to adversely affect the validity of psychological testing. * Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging. * Medications affecting cognition or SWS: * Narcotic analgesics. * Chronic use of medications with anticholinergic activity. * Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegiline). * Others: amphetamines, amphetamine-like compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, gabapentin, pregabalin, trazodone, cholinesterase inhibitors, memantine. * Chronic use of antidepressants are allowed. * History of a first-degree family member with early onset (age \<60 years) dementia. * Short sleepers (\< 5 hours a day) and long sleepers (\> 10 hours a day). * OSA (defined as AHI4%\>15 and AHI4%\>5 with Epworth≥10) * Self-identified as US-born Caribbean Black, Caribbean-born Black or African-born Black.

Inclusion Criteria

Exclusion Criteria

* Male and female subjects with normal cognition and ages 60 to 75.
* Within normal limits on neurological and psychiatric examinations. All subjects enrolled will have a CDR=0.
* An informed family member or life-partner (preferably bed-partner) will be interviewed over the phone or on the first or second visit to confirm the reliability of the subject interview. A study partner is preferably a spouse, close friend, or relative.
* Self-identified as African-American Black or non-Hispanic white.
* All subjects must sign the Alzheimer's Disease Center consent form

* History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
* Significant history of alcoholism based off of the CAGE questionnaire (\>2) or drug abuse.
* History of psychiatric illness (e.g., schizophrenia, bipolar or PTSD)
* Lifelong depression and anxiety will be allowed as long as there has been no active depressive episode within the last two years.
* Geriatric Depression Scale (short form)\>6.
* Insulin dependent diabetes.
* Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions based off of the PI's discretion.
* Physical impairment of such severity as to adversely affect the validity of psychological testing.
* Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
* Medications affecting cognition or SWS:
* Narcotic analgesics.
* Chronic use of medications with anticholinergic activity.
* Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegiline).
* Others: amphetamines, amphetamine-like compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, gabapentin, pregabalin, trazodone, cholinesterase inhibitors, memantine.
* Chronic use of antidepressants are allowed.
* History of a first-degree family member with early onset (age \<60 years) dementia.
* Short sleepers (\< 5 hours a day) and long sleepers (\> 10 hours a day).
* OSA (defined as AHI4%\>15 and AHI4%\>5 with Epworth≥10)
* Self-identified as US-born Caribbean Black, Caribbean-born Black or African-born Black.

Contacts and Locations

Principal Investigator

Ricardo Osorio, MD

PRINCIPAL_INVESTIGATOR

NYU Department of Psychiatry

Study Locations (Sites)

NYU Center for Brain Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Ricardo Osorio, MD, PRINCIPAL_INVESTIGATOR, NYU Department of Psychiatry

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 Date2018-11-21

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2018-11-21

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease