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Aging and Exercise Impacts on Glymphatic Function

2026年8月17日 更新者:Jiaen Liu、University of Texas Southwestern Medical Center

Impact of Aging and Exercise on Glymphatic Function Using Multi-modal MRI

This is a prospective, interventional, non-blinded, single center research project that will recruit cognitively unimpaired subjects in the 25-55 year old and 55-75 year old range. This study will use acute aerobic exercise as a natural intervention model to increase cardiac activity which may further drive the glymphatic function. There will be no randomization, and all enrolled subjects will participate in the exercise session.

Hypotheses: revealed by the multi-modal magnetic resonance imaging (MRI) approach, glymphatic dysfunction increases with age and is associated with preclinical Alzheimer's Disease (AD) pathology in cognitively unimpaired individuals. Using acute aerobic exercise as a human model, the enhancement of cerebrospinal fluid-interstitial fluid (CSF-ISF) exchange caused by elevated cardiac activity and paravascular cerebrospinal fluid (pCSF) dynamics can be validated.

研究概览

详细说明

The purpose of this research study is to understand how the human brain removes amyloid beta (Aβ) protein which can lead to Alzheimer's disease (AD), using non-invasive magnetic resonance imaging (MRI) techniques. Participants will first go through screening including health survey and blood draw. Depending on their age, enrolled participants will take neuropsychological assessment, sleep and quality-of-life survey, exercise testing, MRI and positron emission tomography (PET) scans. Depending on individual age, the study may include up to three separate visits, a blood draw, an MRI visits and a PET scan visit. The greatest risks of this study include the possibility of injury during the exercise testing, MRI and PET scans, and loss of confidentiality.

研究类型

介入性

注册 (估计的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • age 25-75 years old
  • cognitively unimpaired (CU)
  • Mini-Mental State Examination (MMSE) score ≥27 at enrollment screening
  • matched gender
  • all racial/ethnic groups

Exclusion Criteria:

  • pregnant women
  • history of stroke or other major cerebrovascular disease;
  • diagnosis of Alzheimer's disease (AD) or other types of dementia;
  • diagnosis of major neurologic and psychiatric disorders (e.g., Parkingson's disease, major depression);
  • history of prior head trauma, significant autoimmune disorders,
  • sleep apnea;
  • major systemic illness likely to affect the central nervous system, e.g., uncontrolled diabetes, severe cardiovascular disease, cancer, etc.;
  • prior or current alcoholism or drug abuse;
  • resistant hypertension (SBP ≥140 or DBP ≥ 90 mmHg despite 3 antihypertensive drugs at maximal doses);
  • orthostatic hypotension defined as the third standing systolic blood pressure (SBP) < 100mmHg; any contraindications to having a MRI, e.g., claustrophobia, pacemaker or other medical device of metal;
  • any conditions judged by the investigators to be medically inappropriate, risky or likely to cause poor study compliance.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Acute aerobic exercise- Interventional Group
This group will include all enrolled participants from all age groups, will receive MRI scans for glymphatic function and participate in acute aerobic exercise (intervention) between MRI sessions. They may / may not undergo PET scans.
During the MRI session, subject will perform aerobic exercise on a MR-compatible ergometer and will be guided to reach certain heart rate level depending on subject's age. Their vital signs will be closely monitored by the research team to ensure safety.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Exercise-induced changes in heart rate (HR)
大体时间:Baseline (pre-exercise), immediately post-exercise
During exercise, HR will be continuously monitored using photoplethysmography (ppg) by a device attached to a finger of the subjects.
Baseline (pre-exercise), immediately post-exercise
Exercise-induced changes in cardiac output (CO)
大体时间:Baseline (pre-exercise), immediately post-exercise
During exercise, CO will be calculated based on HR and real time blood pressure (BP) acquired on the index finger using an MRI-compatible device.
Baseline (pre-exercise), immediately post-exercise
Exercise-induced changes in MRI measurements of pCSF dynamics
大体时间:Baseline (pre-exercise), immediately post-exercise
pCSF will be assessed using MRI in the brain.
Baseline (pre-exercise), immediately post-exercise
Exercise-induced changes in MRI measurements of CSF-ISF exchange
大体时间:Baseline (pre-exercise), immediately post-exercise
CSF-ISF exchange will be assessed using MRI in the brain.
Baseline (pre-exercise), immediately post-exercise

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jiaen Liu, Ph.D.、University of Texas Southwestern Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).

IPD 共享时间框架

Between the time range beginning 3 months and ending 5 years following publication.

IPD 共享访问标准

Researchers who provide a methodologically sound proposal. Proposals should be directed to Jiaen.Liu@UTSouthwestern.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at NIH's data repository.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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