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临床试验/NCT02555774
NCT02555774已完成不适用

A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Pattern recognition memory test

研究概览

简要总结

This study evaluates the efficacy of cognitive training in subjects with subjective memory impairment. The first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.

详细描述

Subjective memory impairment is currently thought to be a risky state of progression to Alzheimer's disease. This study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition. We include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months. We evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.

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
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named Seoul Neuropsychological Screening Battery (SNSB)
  • Clinical dementia rating (CDR) score of 0
  • Subjects with at least 3 years of formal education

排除标准

  • Subjects with mild cognitive impairment or dementia
  • Subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, Parkinson's disease or brain tumor
  • Subjects with uncontrolled severe medical conditions according to investigator's opinion

研究组 & 干预措施

cognitive training

Experimental

Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session. Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators.

干预措施: cognitive training (Behavioral)

cognitive training

Experimental

Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session. Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators.

干预措施: lifestyle modification (Behavioral)

lifestyle modification

Active Comparator

This group receives only lifestyle modification for 3 months. Lifestyle modification is educated at the first, then weekly phone call for lifestyle modification is done by investigators. The method of lifestyle modification is same with the first arm.

干预措施: lifestyle modification (Behavioral)

No intervention

No Intervention

This group receives no intervention.

结局指标

主要结局

Pattern recognition memory test

时间窗: 3 month

paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The score is shown as correct response rate.%

Spatial working memory test

时间窗: 3 month

paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.

Paired associates learning test

时间窗: 3 month

paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.

Rapid visual information processing test

时间窗: 3 month

rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.%

次要结局

  • cognitive failure questionnaire(3 month)
  • Beck anxiety index(3 month)
  • Seoul instrumental activities of daily living(3 month)
  • Rey complex figure copy test(3 month)
  • Mini-mental state examination(3 month)
  • Logical memory test, delayed recall(3 month)
  • Seoul verbal learning test, immediate recall(3 month)
  • Geriatric depression scale(3 month)
  • Digit symbol test(3 month)
  • Seoul verbal learning test, delayed recall(3 month)

研究者

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

Jae-Hong Lee

Professor

Asan Medical Center

研究点 (1)

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