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临床试验/NCT07775196
NCT07775196尚未招募不适用

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

University of Texas Southwestern Medical Center0 个研究点目标入组 240 人开始时间: 2026年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
主要终点
Exercise-induced changes in heart rate (HR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Exercise-induced changes in heart rate (HR)

时间窗: 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.

Exercise-induced changes in cardiac output (CO)

时间窗: 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.

Exercise-induced changes in MRI measurements of pCSF dynamics

时间窗: Baseline (pre-exercise), immediately post-exercise

pCSF will be assessed using MRI in the brain.

Exercise-induced changes in MRI measurements of CSF-ISF exchange

时间窗: Baseline (pre-exercise), immediately post-exercise

CSF-ISF exchange will be assessed using MRI in the brain.

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

Jiaen Liu

Assistant Professor

University of Texas Southwestern Medical Center

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