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临床试验/NCT01095718
NCT01095718Unknown不适用

Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial

Department of Clinical Research and Innovation1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
The primary outcome of the intervention will be the performance and errors of participants. Each task is comparable as the assessment procedure remains the same across disease stages.

研究概览

简要总结

This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe dementia.

Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions for 6 weeks.

This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:

  1. it will determine which of the of the three learning techniques (EL, MR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
  2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
  3. as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.

详细描述

Scientific background and rationale Alzheimer dementia (AD) is the most common cause of progressive cognitive deterioration that alters memory and learning to such a degree that it heavily interferes with daily living. Functional autonomy loss is a key feature of AD, as it follows a slow degradation process in cognitive function and in the ability to perform instrumental activities of daily living (IADL), such as managing finance, food preparation or using a dish washer. Normally, learning occurs in an unstructured manner, which consists of guessing and the occurrence of errors during acquisition (Trial and Error, TE). However, there is abundant evidence that reducing errors during learning (Errorless Learning, EL) or increasing the time period between recall attempts (Modeling with Spaced Retrieval, MR) allow even moderate and severe Alzheimer Dementia (AD) patients to (re)learn instrumental activities of daily living (IADL) such as using a new route, an agenda or a cassette/radio player. While these findings are encouraging, we still do not fully understand the memory mechanisms underlying different learning techniques that are crucial in improving IADL tasks (re)learning and remembering in AD patients. Because acetyl cholinesterase inhibitors or memantine may be active moderators of intervention targeting memory improvement, complex intervention using behavioral enrichment training should explore any drug treatment by behavioral intervention interaction effects.

Description of the project methodology

This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:

  1. it will determine which of the of the three learning techniques (EL, SR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
  2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks.; and
  3. it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.
  • Primary outcome :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Investigator, 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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary outcome of the intervention will be the performance and errors of participants. Each task is comparable as the assessment procedure remains the same across disease stages.

时间窗: 2 hours - 2 times a week during 6 weeks

次要结局

  • Baseline neuropsychological assessments. Premorbid intelligence level will be estimated by the National Adult Reading Test (NART). The Mini Mental State Examination (MMSE) will be used to assessed cognitive status.(3 times through the trial)

研究者

发起方
Department of Clinical Research and Innovation
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Department of Clinical Research and Innovation

Department of Clinical research and innovation (drc)

Centre Hospitalier Universitaire de Nice

研究点 (1)

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