NCT05728736撤回2 期
Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
Brendan Lucey1 个研究点 分布在 1 个国家开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in CNS tau phosphorylation
研究概览
简要总结
This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers
详细描述
This study will determine the acute effect of lemborexant on CNS tau phosphorylation and other Alzheimer's disease biomarkers in individuals with poor sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60-80 years
- •Any race/ethnicity
- •Mini-Mental Status Examination score (MMSE) ≥ 27
- •Positive plasma amyloid-beta test (i.e., amyloid-positive)
- •Pittsburgh Sleep Quality Index >5
排除标准
- •Cognitive impairment as determined by history of MMSE < 27
- •Inability to speak or understand English
- •Any sleep disorders other than insomnia
- •No history of moderate-to-severe sleep-disordered breathing and STOP-Bang score > 5
- •History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
- •No more than mild sleep apnea (AHI <16) on PSG
- •Sleep schedule outside the range of bedtime 22:00-midnight
- •Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
- •Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
- •Hepatic or renal impairment
- •Pulmonary disease (PI discretion)
- •Type 1 diabetes
- •HIV or AIDS
- •Neurologic or psychiatric disorder requiring medication (PI discretion)
- •Suicidal ideations
- •Alcohol, tobacco or marijuana use (PI discretion)
- •Use of sedating medications (PI discretion)
- •Inability to get out of bed independently
- •In the opinion of the investigator, the participant should be excluded due to an abnormal physical examination.
- •Current pregnancy
- •Body Mass Index >35
- •History of migraines (PI discretion)
- •History of drug abuse in the last 6 months
- •History or presence of any clinically significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI participant is not a good candidate.
- •Urinary or fecal incontinence
- •Concurrently enrolled in another trial of an investigational drug or device
研究组 & 干预措施
treatment
Experimental
20 participants will be randomized to take lemborexant 25mg at h.s for two consecutive nights
干预措施: Lemborexant 25 mg (Drug)
placebo
Placebo Comparator
10 participants will be randomized to take placebo at h.s. for two consecutive nights.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CNS tau phosphorylation
时间窗: 48 hours
Changes in CSF pT181/T181 ratio compared to placebo
次要结局
- Changes in other CSF AD biomarkers(48 hours)
研究者
Brendan Lucey
Principal Investigator, Sleep Medicine Section Head
Washington University School of Medicine
研究点 (1)
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