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Computerized Personal Interventions for Alzheimer's Patients

2011年4月3日 更新者:Shaare Zedek Medical Center
The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.

研究概览

详细说明

Reminiscence therapy and cognitive training are two of the most common non-pharmacological therapies used to treat AD. To date, there is no clear evidence regarding the impact of these treatments on the cognitive function of people with AD. The inconclusive evidence may be due to methodological limitations, the availability of a limited number of controlled studies, the lack of standardized interventions and the need for sensitive assessment tools.

Increasingly, computerized systems are being designed to support both the cognitive assessment of patients with Alzheimer's disease and the administration of novel non-pharmacological interventions. Studies suggest that such systems may be of clear benefit. For example, in an initial study involving patients with AD, computerized cognitive training systems have been shown to be of value in providing a more standardized approach to cognitive training. Also, another study found that the use of a computerized system for reminiscence therapy was successful in facilitating patient-caregiver interaction.

Our research is a collaborative effort designed to test the effects of two such computer-supported interventions in patients with mild AD. The purpose of the research is to compare the efficacy of personalized computerized reminiscence therapy and that of computerized cognitive training to a control group. The reminiscence therapy program is based on developing an internet-based personalized reminiscence system, which will facilitate flexible interactive use by patients and caregivers. The importance of a personalized system is especially salient in immigrant, or in highly mobile, societies due to the heterogeneous background of the patients.

Separate preliminary studies have found positive effects of each system. The research will use various measures to evaluate the efficacy of both treatments, including the Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument, which will serve as the cognitive outcome measure.

研究类型

介入性

注册 (预期的)

159

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beer Sheva、以色列
        • Mental Health Center
      • Jerusalem、以色列
        • Memory Clinic, Shaare Zedek Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinical diagnosis of Alzheimer's Disease
  • MMSE score of 14-26

Exclusion Criteria:

  • Visual impairment
  • Auditory impairment
  • Psychiatric disorders

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:认知训练
Cognitive training using a computerized system
实验性的:Reminiscence therapy
Personalized reminiscence therapy using a computerized system
其他:Control
This group will receive neither of the above interventions or any other similar interventions
Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
大体时间:baseline
baseline
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
大体时间:Baseline+1 month
Baseline+1 month
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
大体时间:Baseline+3 months
Baseline+3 months
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
大体时间:Baseline+6 months
Baseline+6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tzvi Dwolatzky, MD、Mental Health Center, Beer-Sheva

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (预期的)

2012年9月1日

研究完成 (预期的)

2012年9月1日

研究注册日期

首次提交

2011年3月30日

首先提交符合 QC 标准的

2011年4月3日

首次发布 (估计)

2011年4月6日

研究记录更新

最后更新发布 (估计)

2011年4月6日

上次提交的符合 QC 标准的更新

2011年4月3日

最后验证

2011年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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