Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT03814603
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT03814603
Study Brief:
Protocol Section:
NCT03814603