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NCT03814603: Sleep AWARE
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
trial testing PET-MR Scan in Alzheimer Disease in 210 participants. Completed in 31 May 2025.
31 May 2025
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 210 |
| Start date | 21 November 2018 |
| Primary completion | 31 May 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PET-MR Scan
- PiB — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 60 to 75, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03814603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other NYU Langone Health trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03814603 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03814603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing