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NCT03814603 · ClinicalTrials.gov registry record
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 210
- Enrollment target
NCT03814603 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 210 participants.
The verdict
NCT03814603 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 210 participants
- Enrollment target
Study 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).
Interventions
- PROCEDURE PET-MR Scan
- DRUG PiB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2018-11-21 |
| Est. Completion | 2025-05-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03814603
The ClinicalTrials.gov registry entry for NCT03814603 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PET-MR Scan is the first listed.
NCT03814603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03814603 about?
NCT03814603 is a clinical study titled "The Sleep Amyloid, Slow WAve Race and Ethnicity Study". 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 a...
What is the current status of trial NCT03814603?
This trial is currently completed. The enrollment target is 210 participants. The study started on 2018-11-21. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT03814603?
The interventions under investigation include: PET-MR Scan (PROCEDURE), PiB (DRUG).
Who is sponsoring clinical trial NCT03814603?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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