Sleep, Aging and Risk for Alzheimer's Disease (SARA)
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ClinicalTrials.gov Identifier: NCT01962779 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 14, 2013
Last Update Posted
: March 7, 2018
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Condition or disease | Intervention/treatment | Phase |
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Sleep Disordered Breathing Alzheimer's Disease | Device: Continuous positive airway pressure (CPAP) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 224 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Sleep, Aging and Risk for Alzheimer's Disease (SARA) Study |
Actual Study Start Date : | July 31, 2013 |
Actual Primary Completion Date : | April 30, 2017 |
Estimated Study Completion Date : | April 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Continuous positive airway pressure
Moderate to severe SDB subjects will be offered a 6-month therapy with continuous positive airway pressure (CPAP).
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Device: Continuous positive airway pressure (CPAP)
Continuous positive airway pressure (CPAP). CPAP typically is used for people who have breathing problems, such as sleep apnea.
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No Intervention: No intervention
Subjects that refuse treatment with CPAP or that have a poor long-term compliance will be considered controls.
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- Observational. Cerebrospinal fluid (CSF) biomarkers of risk for Alzheimer's disease (AD) in sleep disordered breathing (SDB) subjects. [ Time Frame: Baseline ]At cross section, levels of CSF P-Tau, T-Tau and Aβ42 (in pg/mL) in subjects with SDB
- Observational. Structural MRI hippocampal volume in SDB subjects. [ Time Frame: Baseline ]At cross section, hippocampal volume (in mm3) in subjects with SDB
- Observational. MRI-ASL vasoreactivity response to CO2 challenge in subjects with SDB [ Time Frame: Baseline ]At cross-section, MRI-ASL measured vasoreactivity responses to CO2 (% of brain vasoreactivity to hypercapnia) in subjects with SDB
- Interventional CPAP Clinical Trial, memory changes after CPAP treatment [ Time Frame: Change from baseline in memory tests at 6 months ]All subjects with moderate-to-severe SDB (Apnea Hypopnea Index with 4% desaturation >15) will be prescribed 6-month treatment with CPAP. Changes after treatment in declarative memory (measured using tests from the Wechsler and Guild Memory scales from our neuropsychological battery) at 6 months.
- Interventional CPAP Clinical Trial, CSF biomarker changes after CPAP treatment [ Time Frame: Change from baseline in CSF biomarkers at 6 months ]All subjects with moderate-to-severe SDB (Apnea Hypopnea Index with 4% desaturation >15) will be prescribed 6-month treatment with CPAP. Change after a 6 month treatment in CSF levels of P-Tau (pg/mL), T-Tau (pg/mL) and Aβ42 (pg/mL)
- Interventional CPAP Clinical Trial, MRI biomarker changes [ Time Frame: Change from baseline in MRI biomarkers at 6 months ]All subjects with moderate-to-severe SDB (Apnea Hypopnea Index with 4% desaturation >15) will be prescribed 6-month treatment with CPAP. Changes after a 6 month treatment in brain vasoreactivity response to CO2 (measured by % of vasoreactivity response to hypercapnia) and hippocampal volume in mm3
- Observational. 2-year longitudinal cognitive memory outcomes [ Time Frame: Change from baseline in memory tests at 24 months ]Changes in memory (tests from the Wechsler and Guild Memory scales from our cognitive battery) in SDB-at-baseline subjects (non-treated with CPAP) at the 2-year follow-up
- Observational. 2-year longitudinal AD-biomarker CSF outcomes [ Time Frame: Change from baseline in CSF biomarkers at 24 months ]Changes in CSF P-Tau levels, T-Tau (pg/mL) and Aβ42(pg/mL) in SDB-at-baseline subjects (non-treated with CPAP) at the 2-year follow-up
- Observational. 2-year longitudinal MRI structural and functional outcomes [ Time Frame: Change from baseline in MRI biomarkers at 24 months ]Changes in hippocampal atrophy (mm3) and VR-CO2 responses (% of vasoreactivity response to hypercapnia) in SDB-at-baseline subjects (non-treated with CPAP) at the 2-year follow-up

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male and female subjects with normal cognition and >50 years of age will be enrolled. Younger subjects are not included as the risk for cognitive impairment is too low. Moreover, by selecting this age-range we minimize the possibility of including early-onset genetic forms of neurodegenerative diseases such as Alzheimer's disease and Frontotemporal Dementia.
- Normal subjects will be within normal limits on neurological and psychiatric examinations. All subjects enrolled will have both a Clinical Dementia Rating = 0 and Global Deterioration Scale < 3.
- All subjects will have had a minimum of 12 years education.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 School of Medicine.
- All subjects will have an informed family member or life partner interviewed to confirm the reliability of the subject interview. All subjects will agree to the MRI imaging, the lumbar puncture, apolipoprotein E (ApoE) genotyping and DNA banking
Exclusion Criteria:
- Diagnosis of any brain disease or MRI evidence of brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts are excluded. Subcortical infarcts and white matter lesions are not exclusions.
- History of brain tumor.
- Any radiation or chemotherapy anywhere in the body in the past 3-years.
- Significant history of alcoholism or drug abuse.
- History of psychiatric illness (e.g., schizophrenia, mania, PTSD, or life long history of major depression).
- Hamilton Depression Scale >16 only with history of life long depressive episodes. Otherwise not excluded.
- Evidence of clinically relevant and uncontrolled cardiac, pulmonary, or hypothyroid or hematological conditions. Insulin dependent diabetes and/or history or treated hypertension are not an exclusion. Normal subjects with current levels of HbA1c >5.9% or diabetics >7.0% (American Diabetes Association, 2010) and/or current blood pressure levels >140/90 mm Hg (JNC on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, 2003) will be advised to seek referral.
- Physical impairment of such severity as to adversely affect the validity of psychological testing.
- Hostility or refusal to cooperate.
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- History of a first-degree family member with early onset (before age 65) dementia.
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Medications adversely affecting cognition will result in exclusion. The excluded medications include:
- Antidepressants with anti-cholinergic properties.
- Regular use of narcotic analgesics (>2 doses per week).
- Use of neuroleptics with anti-cholinergic properties.
- Other medications with central nervous system anticholinergic activity.
- Use of Anti-Parkinsonian medications.
- At the baseline individuals taking physician ordered or off-label memory or other cognitive enhancing medications (e.g. cholinesterase inhibitors or memantine) are excluded. At the follow-up these medications are allowed. Also excluded at baseline are individuals taking physician ordered, but off-label memory enhancements. Individuals taking over the counter memory enhancing or protecting medications (e.g. ginkgo biloba, vitamins) are not excluded.
- Patients with significant physical changes (e.g. amputations or loss of sensory input) as these may affect the MRI blood flow measures.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962779
United States, New York | |
NYU Sleep Disorders Center | |
New York, New York, United States, 10016 | |
NYU Center for Brain Health | |
New York, New York, United States, 11222 |
Principal Investigator: | Ricardo S Osorio, MD | Research Assistant Professor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01962779 History of Changes |
Other Study ID Numbers: |
12-03068 R01HL118624 ( U.S. NIH Grant/Contract ) |
First Posted: | October 14, 2013 Key Record Dates |
Last Update Posted: | March 7, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No | |
Pediatric Postmarket Surveillance of a Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by New York University School of Medicine:
Sleep Disordered Breathing Cognitively normal elderly Alzheimer's disease Prevention Continuous positive airway pressure (CPAP) |
Additional relevant MeSH terms:
Alzheimer Disease Respiratory Aspiration Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Respiration Disorders Respiratory Tract Diseases Pathologic Processes |