NCT03278119Active, not recruiting
Sleep Aging and Risk for Alzheimer's 2.0
Sleep Aging and Risk for Alzheimer's Resubmission 2.0
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
Age-related sleep changes and common sleep disorders like obstructive sleep apnea (OSA) may increase amyloid burden and represent risk factors for cognitive decline in the elderly. We will directly interrogate the brain using a 2-night nocturnal polysomnography (NPSG) and amyloid deposition using C-PiB PET/MR both at baseline and at the 24-month follow-up. This study has the potential to identify the mechanisms by which age-related sleep changes contribute to AD neurodegeneration in cognitively normal elderly, the group that could profit the most from sleep preventive strategies.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 158 (actual)
- First submitted
- 7 Sept 2017
- Start date
- 1 May 2018
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Alzheimer disease
- NCT number
- NCT03278119
What you commit to
- Study type: Observational
- Participants enrolled: 158
- From 1 May 2018 to the primary completion date, 25 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- Medications affecting cognition: Narcotic analgesics, chronic use of medications with anticholinergic activity, anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, selegiline). Others: amphetamines, amphetamine-like compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, salicylates, cholinesterase inhibitors and memantine.
Other illness
- 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 or drug abuse.
- History of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long history of major depression).
- Insulin dependent diabetes.
- Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions.
- Physical impairment of such severity as to adversely affect the validity of psychological testing.
- Excessive daytimes sleepiness (Epworth Sleepiness Scale \>10) or history of CVE (arrhythmias, heart valve disease, cardiomyopathy, carotid or coronary artery disease and chest pain) will not be allowed in the OSA groups.
Age
- History of a first-degree family member with early onset (age \<60 years) dementia.
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Geriatric Depression Scale (short form)\>6.
- Irregular sleep-wake rhythms (based on the actigraphy recordings) or severe OSA (AHI4%≥30).
- Chronic use of antidepressants and melatonin are allowed.
Who the study is looking for
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Male and female subjects with normal cognition and 55-75 years.
- Within normal limits on neurological and psychiatric examinations. All subjects enrolled will have a CDR=0.
- All subjects will have had a minimum of 12 years of education. Among minority subjects \>80% of the elderly individuals coming to the NYU-ADC meet this criterion. The education restriction reduces performance variance on cognitive test measures and improves the sensitivity for detecting pathology and disease progression using the robust norms available at NYU. Given most subjects will meet this criterion we do not consider this a major selection bias or generalization limitation for this study.
- An informed family member or life-partner (preferably bed-partner) will be interviewed to confirm the reliability of the subject interview.
Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healthy Brain Aging and Sleep Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.