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临床试验/NCT01978353
NCT01978353已完成不适用

Episodic Memory Training for Face Name Association in Patients With Amnestic Mild Cognitive Impairment: Cognitive Measures and Functional Resonance Magnetic Imaging Outcomes

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年11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
30
试验地点
2
主要终点
Changes in functional magnetic resonance imaging (fMRI)

研究概览

简要总结

Preview research reports evidence of cognitive plasticity among individuals with amnestic Mild cognitive Impairment, and small-size studies have suggest that this population can benefit from memory training. This project intends to assess the efficacy of cognitive training in persons with MCI with a randomized controlled design.

The hypothesis is that cognitive training can improve memory performance for persons with amnestic mild cognitive impairment and this improvement can be maintained over time.

详细描述

Mild Cognitive Impairment (MCI) often represents a transitional state between healthy aging and dementia, being considered a public health problem especially due to the increase of elder population in Brazil and in the World in general. Yet the conclusions of studies on pharmacological treatments for this population are still controversial, making imperative to invest on new efficient therapies such as non pharmacological interventions aimed at memory improvement.

One training mode that has benefited elders is the association between names and faces, which has a compelling clinical relevance considering that one of the main complains among elders is the difficulty in remembering names. However, the exact effects of this kind of training in elders (i.e. the eventual changes in cognition and in brain activation on Magnetic Resonance Imaging) are still unclear.

Therefore, this study aims to verify the effects of memory training (name-face association) compared with control intervention - psychoeducation, in 30 elders with amnestic MCI. We will request the participants with amnestic MCI to submit to a Cerebrospinal Fluid (CSF) in order to improve the accuracy of the diagnosis. Training and psychoeducation will be conducted in 4 sessions (two per week). To assess the effects, we will use cognitive instruments and MRI exams before and after the intervention. Also, one and three months after the conclusion of the training patients will again be submitted to cognitive tests.

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

  • Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent.

排除标准

  • History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study.

结局指标

主要结局

Changes in functional magnetic resonance imaging (fMRI)

时间窗: Baseline and within two weeks after intervention

fMRI correlates of behavioral performance at face-name task

Changes in memory measures

时间窗: Baseline and within two weeks after intervention

Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)

次要结局

  • Changes in memory performance and perception of memory performance over time - follow up(One and three months after intervention)
  • Changes in perception of memory performance and mood(Baseline, within two weeks after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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