The Sleep Amyloid, Slow WAve Race and Ethnicity Study

Alzheimer Disease Clinical Trial

— Sleep AWARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03814603
• Other study ID #: s18-01302
• Status: Recruiting
• Start date: November 21, 2018
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Oliver Cesar
• Phone: 646-754-2244
• Email: Oliver.Cesar[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Procedure:
• PET-MR Scan
Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.

Drug:
• PiB
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.

Locations

Country	Name	City	State
United States	NYU Center for Brain Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Determined at baseline.
Primary	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.	Baseline and 2.5 year follow-up
Primary	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.	Baseline and 2.5 year follow-up