Investigating sleep patterns and amyloid levels in African-Americans and whites

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

This study is trying to see if better sleep quality and quantity can lower amyloid levels in the brains of older African-Americans and whites, who are at risk for Alzheimer's disease.

Quick facts

• Study type: Observational
• Enrollment: 210 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03814603 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between sleep quality and quantity, specifically slow wave sleep, and amyloid burden in cognitively normal elderly individuals aged 60-75. The research focuses on African-Americans, who have a higher prevalence of Alzheimer's disease and associated vascular risk factors compared to whites. By conducting community outreach in Brooklyn and other NYC boroughs, the study will recruit participants to undergo PET-MR scans to assess amyloid levels. The goal is to identify potential physiological differences in Alzheimer's risk related to sleep patterns among different racial groups.

Who should consider this trial

Good fit: Ideal candidates are cognitively normal African-American individuals aged 60-75.

Not a fit: Patients with significant neurological disorders or a history of psychiatric illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the role of sleep in Alzheimer's disease risk, potentially leading to targeted interventions for at-risk populations.

How similar studies have performed: While studies have explored the relationship between sleep and Alzheimer's, this specific focus on racial differences and sleep's impact on amyloid levels is relatively novel.

Eligibility criteria

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.

Where this trial is running

New York, New York

• NYU Center for Brain Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Ricardo Osorio, MD — NYU Department of Psychiatry
• Study coordinator: Oliver Cesar

Conditions: Alzheimer Disease