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临床试验/NCT02001441
NCT02001441已完成不适用

Physical Activity Levels and Hippocampal Sub-region Structure in MCI

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年8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
35
试验地点
1
主要终点
Activity level correlation with hippocampal thickness

研究概览

简要总结

This project will examine the relationship between physical activity levels, brain structure and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study will follow 30 adults with age-associated memory impairment or MCI over the course of 18 months. During this time, subjects' physical activity levels will be measured regularly and related to both the thickness their hippocampus and to their memory performance. Subjects will be recruited and screened for major health problems at UCLA. Physical activity will be tracked for two weeks using accelerometers at baseline and every 6 months during the study. At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory function. The study will seek to determine the relationship between physical activity level, hippocampal thickness and memory performance in older adults with age-associated memory impairment.

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
60 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Agreement to participate in the study
  • 60-89 years of age
  • Diagnostic criteria for Mild Cognitive Impairment diagnosis: subjective memory complaints, Montreal Cognitive Assessment score of <26, intact instrumental activities of daily living (Smith et al., 1996) OR subjective age-associated memory complaints
  • Cohabitation with an adult capable of ensuring correct usage of the physical activity monitors during the study and verifying self-reports of activity levels.
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Screening laboratory tests and EKG without significant abnormalities that might interfere with the study. If screening laboratory tests or EKG show abnormalities, PI may request clearance from primary care physician before subject continues in study.

排除标准

  • Comorbid conditions impacting mobility
  • Current, untreated depression: BDI-II score >13
  • Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal).
  • Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of head trauma, stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
  • Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain medical implants or previous abnormal MRI results.
  • History of cardiovascular disease
  • Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)
  • Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000), including current alcoholism or substance addiction.
  • Current use of marijuana
  • Previous use of marijuana for at least 15 days in a month, initiating use during adolescence and continuing for at least one year

结局指标

主要结局

Activity level correlation with hippocampal thickness

时间窗: 18 months

Correlation of activity levels, as measured using ankle accelerometers, with hippocampal thickness, as measured using brain Magnetic Resonance Imaging (MRI).

次要结局

  • Activity level correlation with memory performance(18 months)

研究者

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

David Merrill, MD, PhD

Assistant Professor

University of California, Los Angeles

研究点 (1)

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