Alzheimer DiseaseSleep AWARENCT03814603
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
An observational study of Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PET-MR Scan and PiB
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 31 May 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Center for Brain Health
New York, New York, 10016
About this study
Official title: 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).
- Conditions
- Alzheimer Disease
- Being tested
- PET-MR Scan, PiB
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MR ScanProcedure or surgery
Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.
PiBDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| African Americans | Not described Receives: Procedure: PET-MR Scan; Drug: PiB | |
| Non-Hispanic Whites | Not described Receives: Procedure: PET-MR Scan; Drug: PiB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA).
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.
Measured: Determined at baseline.
Examine association between SWS duration and poor SWA with longitudinal change in amyloid burden.
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.
Measured: 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.
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.
Measured: Baseline and 2.5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start21 Nov 2018
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Ricardo Osorio, MD, Principal investigator, NYU Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814603
- Sponsor's protocol ID
- s18-01302
- Acronym
- Sleep AWARE
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03814603
- Acronym / sponsor ID
- Sleep AWARE / s18-01302
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African Americans | – | Procedure: PET-MR Scan, Drug: PiB |
| Non-Hispanic Whites | – | Procedure: PET-MR Scan, Drug: PiB |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MR ScanParticipants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally. | Procedure or surgery | African Americans, Non-Hispanic Whites |
| PiBSubjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection. | Drug | African Americans, Non-Hispanic Whites |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Osorio, MD principal investigator
NYU Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA). (time frame: Determined at baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.