Status:
COMPLETED
The Sleep Amyloid, Slow WAve Race and Ethnicity Study
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-75 years
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03814603
Start Date
November 21 2018
End Date
May 31 2025
Last Update
September 22 2025
Active Locations (1)
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1
NYU Center for Brain Health
New York, New York, United States, 10016