跳至主要内容
临床试验/NCT04118985
NCT04118985已完成不适用

Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
21
试验地点
2
主要终点
BrainHQ

研究概览

简要总结

The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age 50 or older
  • A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?')
  • Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education)
  • Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8)
  • English speaking
  • Approval letter from a physician (due to the exercise component)

排除标准

  • Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.)
  • Uncontrolled moderate or severe depression (e.g., CES-D > 21).

结局指标

主要结局

BrainHQ

时间窗: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

Number of minutes on BrainHQ computer exercise program

Everyday Compensation Questionnaire

时间窗: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use

Lifestyle Activities Questionnaire

时间窗: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

self-report of cognitive activities, range 13-65 with higher scores indicating more activity

Mindful Attention Awareness Scale

时间窗: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience

Physical Activities Questionnaire

时间窗: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed.

次要结局

  • Quality of Life (in aging and cognitive health)(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • Psychological well-being(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • cognitive measure of executive functioning(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • cognitive measure of verbal fluency(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • Everyday Cognition(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • Centers for Epidemiological Studies - Depression(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • Cognitive measure of memory(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • cognitive measure of response inhibition(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)
  • cognitive measure of visual scanning speed(baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dona E. Locke

Principal Investigator

Mayo Clinic

研究点 (2)

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