- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814603
The Sleep Amyloid, Slow WAve Race and Ethnicity Study (Sleep AWARE)
March 28, 2024 updated by: NYU Langone Health
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
210
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oliver Cesar
- Phone Number: 646-754-2244
- Email: Oliver.Cesar@nyulangone.org
Study Contact Backup
- Name: Anouar Smith
- Phone Number: 212-263-7795
- Email: anouar.smith@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Center for Brain Health
-
Contact:
- Dishari Azad
- Phone Number: 646-754-2229
- Email: Dishari.azad@nyulangone.org
-
-
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.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
210 cognitively normal elderly (Clinical Dementia Rating [CDR]=0), self-identified as African-American (AA) or non-Hispanic white (NHW), ages 60 to 75 years, with English as their primary language
Description
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
African Americans
|
Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.
Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.
|
Non-Hispanic Whites
|
Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.
Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA).
Time Frame: Determined at baseline.
|
Aim 1 will test if individual % African ancestry (%AF), estimated from 0-100 and computed using a maximum likelihood method for inferring individual admixture based upon allele frequencies ascertained from Utah residents with Northern and Western European ancestry and West African samples, is associated with short SWS duration/ and poor slow wave activity (SWA), determined through polysomnography, in older AAs while controlling for other moderating factors.
|
Determined at baseline.
|
Examine association between SWS duration and poor SWA with longitudinal change in amyloid burden.
Time Frame: Baseline and 2.5 year follow-up
|
Aim 2 will test the effect of race and its interaction with baseline SWS duration and SWA with amyloid plaque burden both at baseline and follow-up by determining mean PiB standard uptake value using PET-MR.
|
Baseline and 2.5 year follow-up
|
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.
Time Frame: Baseline and 2.5 year follow-up
|
Aim 3 will test the effect of race and baseline SWS duration and poor SWA on overall cognition using standardized and sleep-dependent tests: the UDS 3.0, WHICAP Clinical Core Neuropsychological test battery, as well as a 3-D Virtual Maze Task, both at baseline and follow-up.
|
Baseline and 2.5 year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ricardo Osorio, MD, 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 Major Dates
Study Start (Actual)
November 21, 2018
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
December 27, 2018
First Submitted That Met QC Criteria
January 18, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s18-01302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Subjects will have the option to allow their leftover blood and DNA samples to be banked indefinitely for future research related to studies on early diagnosis of Alzheimer's, disease and/or mechanism of neurodegeneration.
After the study is completed, the de-identified, archived data will be transmitted to and stored at the CBH Biorepository, under the supervision of Dr. Osorio, for use by other researchers including those outside of the study.
Permission to transmit data to the CBH Biorepository will be included in the ICF.
During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research.
However, withdrawal of consent with regard to biosample storage will not be possible after the study is completed.
When the study is completed, access to study data and/or samples will be provided through the CBH Biorepository.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on PET-MR Scan
-
Tel-Aviv Sourasky Medical CenterUnknownSarcoma | Lymphoma | Cervical Cancer | Nasopharyngeal Cancer | Pancreatic Cancer | Esophageal Cancer | Prostate Cancer | Hepatobiliary Cancer
-
Tel-Aviv Sourasky Medical CenterUnknownNeuroendocrine Tumors
-
Mayo ClinicCompletedAmyloidosisUnited States
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Tel-Aviv Sourasky Medical CenterUnknownLymphoma | Follicular Lymphoma | Non Hodgkin Lymphoma
-
Tel-Aviv Sourasky Medical CenterUnknown
-
King's College LondonRecruiting
-
Heike E Daldrup-LinkRecruiting
-
University of EdinburghBritish Heart FoundationCompletedCoronary Artery Disease | MRI | Cardiovascular Disease | Magnetic Resonance Imaging | Positron-Emission Tomography | PET ScanUnited Kingdom