NCT03814603Completed
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 210 (actual)
- First submitted
- 27 Dec 2018
- Start date
- 21 Nov 2018
- Primary completion date
- 31 May 2025
- Lead sponsor
- NYU Langone Health
- Diseases
- Alzheimer disease
- NCT number
- NCT03814603
What you commit to
- Study type: Observational
- Participants enrolled: 210
- From 21 Nov 2018 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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)
- 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.
Age
- History of a first-degree family member with early onset (age \<60 years) dementia.
Other
- 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.
- Chronic use of antidepressants are allowed.
- 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.
Who the study is looking for
- 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
Age in the registry: 60 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Center for Brain Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.