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临床试验/NCT01021644
NCT01021644已完成不适用

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Howard University4 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
4
主要终点
AD Assessment Scale-Cognitive (ADAS-COG)

研究概览

简要总结

The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.

详细描述

This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age over 60 years
  • Ability to exercise vigorously without harm
  • Study partner
  • In good general health
  • Willing to exercise for 6 months
  • Body Mass Index (BMI) less than 37
  • Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study

排除标准

  • MMSE score below 20
  • TG (Triglyceride) greater than 400 mg/dl
  • LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms

结局指标

主要结局

AD Assessment Scale-Cognitive (ADAS-COG)

时间窗: baseline, 3 and 6 months

次要结局

  • Geriatric Depression Scale(baseline and 6 months)
  • Logical Memory Test (Delayed Paragraph Recall)(baseline and 6 months)
  • Neuropsychiatric Inventory Q (NPIQ)(baseline and 6 months)
  • Activities of Daily Living (ADCS-ADL)(baseline and 6 months)
  • PET imaging to measure cerebral glucose homeostasis/metabolism(baseline and 6 months)
  • Mini-Mental State Exam (MMSE)(baseline, 3 and 6 months)
  • CDR (Clinical Dementia Rating) Scale(baseline, 3 and 6 months)
  • Visuospatial and Visuographic: Clock Drawing Test(baseline and 6 months)
  • American National Adult Reading Test (ANART)(baseline and 6 months)

研究者

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

Thomas Obisesan

Professor of Medicine

Howard University

研究点 (4)

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