跳至主要内容
临床试验/NCT05601856
NCT05601856招募中不适用

Gut Microbiome and Blood Indices in Patients with AD and Their Spousal Caregivers

University of Virginia1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
104
试验地点
1
主要终点
Inflammation related biomarkers

研究概览

简要总结

Spousal caregivers of Alzheimer's Dementia (AD) patients have an elevated risk of developing AD in the future. Past studies have shown the presence of serum indicators correlated with gut biome dysfunction in AD patients. We hypothesize that the same gut biome dysfunction may be present in spousal caregivers of AD patients.

详细描述

Patients with Alzheimer's disease (AD) have gut dysbiosis. Short-chain fatty acids (SCFAs) are products of the gut microbiome. Among them, Acetate and valeric acid were positively correlated with the Aβ plaque load detected by amyloid PET in participants with or without AD. However, the levels of SCFAs in the blood of patients with AD have not been defined. Also, the usefulness of indices of inflammation and neuropathology in the blood as biomarkers for cognitive impairment in patients with AD is elusive. Importantly, spousal caregivers of patients with dementia have a higher risk of developing dementia later in life than those whose spouses do not have dementia. The spousal caregivers have an accelerated cognitive decline. The mechanisms for these phenomena are not known. We hypothesize that spousal caregivers of patients with AD have gut microbiome and levels of blood SCFAs similar to those of patients with AD, that these spouses have increased inflammatory cytokines and indices of AD-like neuropathology in the blood, and that there is a correlation between the cognition and various indices in the blood among patients with AD, their spouses, and age-matched controls. To address these hypotheses, we will recruit three groups of participants: Patients with AD, their spousal caregivers, and controls that are age-matched with the caregivers. Their gut microbiome and indices of neuroinflammation and neuropathology in the blood will be determined. Their cognition will be assessed. The correction of cognition with gut microbiome genera or indices in the blood will be analyzed. Our studies may represent the first study to determine whether the gut microbiome and SCFAs may play a role in the cognitive impairment in the spousal caregivers of patients with AD. These studies may also identify biomarkers for cognitive impairment in these caregivers and patients with AD. These findings may ultimately help the care of patients with AD and reduce the cognitive declines in spousal caregivers of patients with AD.

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
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with AD whose clinical dementia rating (CDR) is > 1
  • Spouses of Patients in the above group Or
  • Healthy adult unrelated to groups 1 and 2, with no history of dementia And
  • Regardless of the grouping, the prospective subject must be between 65 and 90 years old

排除标准

  • Familial Alzheimer's Disease (AD)
  • Severe cardiovascular disease
  • Severe respiratory system disease
  • Severe liver disease
  • Severe kidney disease
  • Severe central nervous system diseases
  • Having a lifespan of fewer than 3 months
  • History of psychiatric illness
  • Major neurological diseases other than AD
  • Current use of corticosteroids, antibiotics, or bowel motility modification agents
  • Any history of Alcoholism or illicit drug dependence
  • Previous inclusion in this study
  • Difficulty with follow-up or poor compliance
  • Severe hearing impairment
  • Severe vision impairment

结局指标

主要结局

Inflammation related biomarkers

时间窗: one day

interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40

ratio of Aβ1-42 and Aβ1-40

时间窗: one day

total tau biomarker

时间窗: one day

amyloid biomarker

时间窗: one day

amyloid beta (Aβ)1-42

phospho-tau at 181 or 217 biomarker

时间窗: one day

neurodegeneration related biomarkers

时间窗: one day

neurofilament light chain (NFL) and neurogranin

serum short chain fatty acids

时间窗: one day

acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiyi Zuo, MD

Professor, Anesthesiology

University of Virginia

研究点 (1)

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