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Sleep Aging and Risk for Alzheimer's 2.0 | Clinical Trials | Clareo Health

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Sleep Aging and Risk for Alzheimer's 2.0

Sleep Aging and Risk for Alzheimer's Resubmission 2.0

NCT03278119•NYU Langone Health

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.

Eligibility

Age

55 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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

•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 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.
+4 more criteria

Locations (1)

Healthy Brain Aging and Sleep Center

New York, New York, United States

Key Dates

Start Date

May 1, 2018

Primary Completion Date

December 25, 2025

Completion Date

December 25, 2025

Last Updated

May 30, 2025

Enrollment

158

ACTUAL participants

Conditions

Alzheimer DiseaseSleep Apnea

Interventions

PET Scan and nocturnal polysomnography

DIAGNOSTIC_TEST

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

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RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sleep Aging and Risk for Alzheimer's 2.0

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

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Digital-supported Orofacial Myofunctional Therapy in OSA

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy