The Sleep Amyloid, Slow WAve Race and Ethnicity Study (NCT03814603) | Clinical Trial Compass
CompletedNot Applicable
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
United States210 participantsStarted 2018-11-21
Plain-language summary
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).
Who can participate
Age range
60 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA).
Timeframe: Determined at baseline.
2
Examine association between SWS duration and poor SWA with longitudinal change in amyloid burden.
Timeframe: Baseline and 2.5 year follow-up
3
Examine the association between race, SWS duration and poor SWA and cognition using both standardized and sleep-dependent cognitive tests at baseline and follow-up.