Alzheimer DiseaseSARANCT03278119
Sleep Aging and Risk for Alzheimer's 2.0
An observational study of Alzheimer Disease and Sleep Apnea, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Sleep Apnea
- What is being tested?
- PET Scan and nocturnal polysomnography
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 25 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%<30).
Who may be able to join
- 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.
Who cannot join
- 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.
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- Evidence of clinically relevant 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Brain Aging and Sleep Center
New York, New York, 10016
About this study
Official title: Sleep Aging and Risk for Alzheimer's Resubmission 2.0
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.
- Conditions
- Alzheimer Disease, Sleep Apnea
- Being tested
- PET Scan and nocturnal polysomnography
- Medical subject headings
- Alzheimer Disease, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Scan and nocturnal polysomnographyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: PET Scan and nocturnal polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
Measured: 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.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 May 2018
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ricardo Osorio, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278119
- Sponsor's protocol ID
- 17-01005
- Other IDs
- R01AG056031
- Acronym
- SARA
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2017
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Aging and Risk for Alzheimer's Resubmission 2.0
- ClinicalTrials.gov ID
- NCT03278119
- Acronym / sponsor ID
- SARA / 17-01005
- Conditions
- Alzheimer Disease, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea | – | Diagnostic Test: PET Scan and nocturnal polysomnographyOverall 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 |
| No Sleep Apnea | – | Diagnostic Test: PET Scan and nocturnal polysomnographyOverall 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 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%<30).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET Scan and nocturnal polysomnographyAmyloid PET scans will be used to assess amyloid burden in the brain, and nocturnal polysomnography will be used to assess sleep and cardiopulmonary variables | Diagnostic test | No Sleep Apnea, Sleep Apnea |
Primary outcome
Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
Time frame: 2.5 years
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Osorio, MD principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Sleep Apnea, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD. (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.