Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- sST2
研究概览
简要总结
Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD.
A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Able to swallow trazodone capsules
- •Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
- •A diagnosis of mild cognitive impairment (MCI)
- •A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index > 5
- •Neuroimaging obtained during screening consistent with a clinical diagnosis of Alzheimer's disease (AD) and without findings of significant exclusionary abnormalities
- •Written informed consent to participate in the study provided by the patient
排除标准
- •Diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system
- •Vitamin B12 or folate deficiency
- •Diagnosis of mental health disorders
- •Nootropic drugs except for AD prescriptions stable for at least 30 days
- •Suspected or known allergy to trazodone
- •Intake of drugs or substances potentially involved in clinically significant inhibition or induction of CYP34A or P-gp-medicate drug interactions with trazodone within 4 weeks or 5 half-lives of the interacting drug prior to administration of trazodone and throughout the course of the study
- •Previous exposure to anti-Aβ vaccines
- •Concurrent treatment with antipsychotic agents, antiepileptics centrally active antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines within 4 weeks of screening visit
- •Patients who are receiving non-benzodiazepine hypnotics
- •Clinically significant, advanced, or unstable disease that might interfere with outcome evaluations
研究组 & 干预措施
Trazodone
干预措施: Trazodone (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
sST2
时间窗: Baseline, Week 4, 13, 26 and 52
The change of plasma sST2 levels
Clinical Dementia Rating Score
时间窗: Baseline, Week 26 and 52
The change in Clinical Dementia Rating global score
次要结局
未报告次要终点
研究者
Timothy Kwok
Professor
Chinese University of Hong Kong