NCT03278119进行中（未招募）不适用
Sleep Aging and Risk for Alzheimer's Resubmission 2.0
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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=
- •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.
排除标准
- •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)>
- •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.
- •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.
结局指标
主要结局
Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
时间窗: 2.5 years
次要结局
- Establishing that SWS quality is associated with longitudinal amyloid deposition will identify a key mechanism by which age increases AD risk.(2.5 years)
研究者
研究点 (1)
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