ClinicalTrials.gg
Active, not recruitingNCT03278119SARAUpdated Mar 30, 2026

Sleep Aging and Risk for Alzheimer's 2.0

An observational study in Alzheimer Disease and Sleep Apnea, sponsored by NYU Langone Health. Active, not recruiting at 1 site in United States. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
158
Ages
55 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Alzheimer Disease by NYU Langone Health — 2 open to participants now, 4 under way, none of them phase 3. Alzheimer Disease · NYU Langone Health.

Started
2018
with 4 others
Observational
7 of 22
none open now
Registered
12th of 22
by date

Among the 22 studies in Alzheimer Disease by NYU Langone Health, this one is one of 5 that started in 2018, is one of 7 observational ones, and was the 12th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phase8 · 0 open
Observationalthis study7 · 0 open
Phase 44 · 1 open
Phase 12 · 1 open
Phase 21 · 0 open

By the year they started

First in 2005; this study’s year is marked. 5 started in 2018.

Size and results

Median enrollment 34 across the 15 interventional studies, 81 across the 7 observational. Of the 17 that completed or were terminated, 5 (29%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Alzheimer Disease by NYU Langone Health, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Alzheimer Disease
  • Sleep Apnea
04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%\<30).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • 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).
  • Geriatric Depression Scale (short form)>6.
  • Insulin dependent diabetes.
  • Evidence of cardiac, pulmonary, endocrine or hematological conditions.
  • 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: 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.
  • History of a first-degree family member with early onset (age \<60 years) dementia.
  • Irregular sleep-wake rhythms (based on the actigraphy recordings) or severe OSA (AHI4%≥30).
  • Chronic use of antidepressants and melatonin are allowed.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
158 participants (actual)
Patient registry
No

Groups and cohorts

  • Sleep Apnea

    Overall 56 * both male and female * age group 55 to 75 years, having mild to severe obstructive sleep apnea * in good general health with no significant comorbidities * Located for the most part in boroughs of New York City

    Diagnostic Test: PET Scan and nocturnal polysomnography

  • No Sleep Apnea

    Overall 56 * both male and female * age group 55 to 75 years, without OSA * in good general health with no significant comorbidities * Located for the most part in boroughs of New York City

    Diagnostic Test: PET Scan and nocturnal polysomnography

Interventions

  • Diagnostic testPET Scan and nocturnal polysomnography

    Amyloid PET scans will be used to assess amyloid burden in the brain, and nocturnal polysomnography will be used to assess sleep and cardiopulmonary variables

06

What researchers measure

Primary outcomes

  1. Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.

    Time frame: 2.5 years

Secondary outcomes

  1. Establishing that SWS quality is associated with longitudinal amyloid deposition will identify a key mechanism by which age increases AD risk.

    Time frame: 2.5 years

07

Study locations

1 site
  • Healthy Brain Aging and Sleep Center
    New York, New York 10016, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2018 (actual). Primary completion is estimated for Dec 2026, 103 months after the start.

Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 103 months is above that.

Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Sep 11, 2017
StartActual
May 1, 2018
Primary completionEst.
Dec 25, 2026
CompletionEst.
Dec 25, 2026
Last update
Mar 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03278119
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Sep 11, 2017
Start date
May 1, 2018
Primary completion
Dec 25, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Mar 30, 2026

Study contacts

Ricardo Osorio, MD
principal investigator · New York Langone Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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